Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19 (NCT NCT04425629)
NCT ID: NCT04425629
Last Updated: 2023-12-21
Results Overview
Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
10078 participants
Primary outcome timeframe
Through Day 29
Results posted on
2023-12-21
Participant Flow
10065 were randomized, 135 randomized but not treated
Participant milestones
| Measure |
Phase 1 Symptomatic: Placebo
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 1 Symptomatic: 2.4 IV
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 1 Symptomatic: 8.0 IV
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic: Placebo
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic: 2.4 IV
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic: 8.0 IV
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Asymptomatic: Placebo
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic: 2.4 IV
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic: 8.0 IV
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Age>=18: Placebo
Placebo of R10933 + R10987 Participants \>= 18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18: 1.2 IV
1.2g of R10933 + R10987 Participants \>= 18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18: 2.4 IV
2.4g of R10933 + R10987 Participants \>= 18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18: 8.0 IV
8.0g of R10933 + R10987 Participants \>= 18 with COVID-19, not pregnant at randomization
|
Phase 3 Age <18: Placebo
Placebo of R10933 + R10987 Participants \<18 with COVID-19, not pregnant at randomization
|
Phase 3 Age <18: 1.2 IV
1.2g of R10933 + R10987 Participants \<18 with COVID-19
|
Phase 3 Age <18: 2.4 IV
2.4g of R10933 + R10987 Participants \<18 with COVID-19
|
Phase 3 Pregnant Placebo
Placebo of R10933 + R10987 Participants who are pregnant with COVID-19
|
Phase 3 Pregnant 1.2 IV
1.2g of R10933 + R10987 Participants who are pregnant with COVID-19
|
Phase 3 Pregnant: 2.4 IV
2.4g of R10933 + R10987 Participants who are pregnant with COVID-19
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
242
|
242
|
243
|
76
|
76
|
76
|
2378
|
2156
|
3189
|
1027
|
2
|
129
|
75
|
3
|
43
|
36
|
|
Overall Study
COMPLETED
|
23
|
19
|
22
|
230
|
232
|
233
|
71
|
73
|
74
|
2217
|
1974
|
2947
|
962
|
2
|
123
|
65
|
2
|
40
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
2
|
12
|
10
|
10
|
5
|
3
|
2
|
161
|
182
|
242
|
65
|
0
|
6
|
10
|
1
|
3
|
3
|
Reasons for withdrawal
| Measure |
Phase 1 Symptomatic: Placebo
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 1 Symptomatic: 2.4 IV
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 1 Symptomatic: 8.0 IV
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic: Placebo
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic: 2.4 IV
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic: 8.0 IV
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Asymptomatic: Placebo
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic: 2.4 IV
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic: 8.0 IV
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Age>=18: Placebo
Placebo of R10933 + R10987 Participants \>= 18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18: 1.2 IV
1.2g of R10933 + R10987 Participants \>= 18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18: 2.4 IV
2.4g of R10933 + R10987 Participants \>= 18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18: 8.0 IV
8.0g of R10933 + R10987 Participants \>= 18 with COVID-19, not pregnant at randomization
|
Phase 3 Age <18: Placebo
Placebo of R10933 + R10987 Participants \<18 with COVID-19, not pregnant at randomization
|
Phase 3 Age <18: 1.2 IV
1.2g of R10933 + R10987 Participants \<18 with COVID-19
|
Phase 3 Age <18: 2.4 IV
2.4g of R10933 + R10987 Participants \<18 with COVID-19
|
Phase 3 Pregnant Placebo
Placebo of R10933 + R10987 Participants who are pregnant with COVID-19
|
Phase 3 Pregnant 1.2 IV
1.2g of R10933 + R10987 Participants who are pregnant with COVID-19
|
Phase 3 Pregnant: 2.4 IV
2.4g of R10933 + R10987 Participants who are pregnant with COVID-19
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
3
|
2
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
1
|
7
|
1
|
2
|
1
|
0
|
1
|
64
|
70
|
98
|
30
|
0
|
5
|
4
|
0
|
3
|
1
|
|
Overall Study
Subject Decision
|
0
|
2
|
1
|
3
|
6
|
6
|
3
|
3
|
1
|
70
|
95
|
124
|
25
|
0
|
1
|
4
|
1
|
0
|
2
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Sponsor Request
|
0
|
0
|
0
|
2
|
2
|
2
|
1
|
0
|
0
|
9
|
9
|
10
|
8
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
3
|
5
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19
Baseline characteristics by cohort
| Measure |
Phase 1 Symptomatic: Placebo
n=24 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 1 Symptomatic: 2.4 IV
n=24 Participants
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 1 Symptomatic: 8.0 IV
n=24 Participants
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic: Placebo
n=242 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic: 2.4 IV
n=242 Participants
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic: 8.0 IV
n=243 Participants
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Asymptomatic: Placebo
n=76 Participants
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic: 2.4 IV
n=76 Participants
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic: 8.0 IV
n=76 Participants
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Age>=18: Placebo
n=2378 Participants
Placebo of R10933 + R10987 Participants \>=18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18: 1.2 IV
n=2156 Participants
1.2g of R10933 + R10987 Participants \>=18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18: 2.4 IV
n=3189 Participants
2.4g of R10933 + R10987 Participants \>=18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18: 8.0 IV
n=1027 Participants
8.0g of R10933 + R10987 Participants \>=18 with COVID-19, not pregnant at randomization
|
Phase 3 Age <18: Placebo
n=2 Participants
Placebo of R10933 + R10987 Participants \<18 with COVID-19, not pregnant at randomization
|
Phase 3 Age <18: 1.2 IV
n=129 Participants
1.2g of R10933 + R10987 Participants \<18 with COVID-19
|
Phase 3 Age <18: 2.4 IV
n=75 Participants
2.4g of R10933 + R10987 Participants \<18 with COVID-19
|
Phase 3 Pregnant Placebo
n=3 Participants
Placebo of R10933 + R10987 Participants who are pregnant with COVID-19
|
Phase 3 Pregnant 1.2 IV
n=43 Participants
1.2g of R10933 + R10987 Participants who are pregnant with COVID-19
|
Phase 3 Pregnant: 2.4 IV
n=36 Participants
2.4g of R10933 + R10987 Participants who are pregnant with COVID-19
|
Total
n=10065 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.5 years
n=5 Participants
|
39.5 years
n=7 Participants
|
39.0 years
n=5 Participants
|
42.0 years
n=4 Participants
|
43.0 years
n=21 Participants
|
42.0 years
n=8 Participants
|
43.5 years
n=8 Participants
|
44.5 years
n=24 Participants
|
44.5 years
n=42 Participants
|
46.0 years
n=42 Participants
|
48.0 years
n=42 Participants
|
46.0 years
n=42 Participants
|
44.0 years
n=36 Participants
|
14.0 years
n=36 Participants
|
11.0 years
n=24 Participants
|
12.0 years
n=135 Participants
|
33.0 years
n=136 Participants
|
30.0 years
n=44 Participants
|
28.0 years
n=667 Participants
|
45.0 years
n=12 Participants
|
|
Age, Customized
<18
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
129 Participants
n=24 Participants
|
75 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
207 Participants
n=12 Participants
|
|
Age, Customized
>=18, <65
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
226 Participants
n=4 Participants
|
223 Participants
n=21 Participants
|
228 Participants
n=8 Participants
|
71 Participants
n=8 Participants
|
62 Participants
n=24 Participants
|
65 Participants
n=42 Participants
|
2159 Participants
n=42 Participants
|
1937 Participants
n=42 Participants
|
2843 Participants
n=42 Participants
|
911 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
43 Participants
n=44 Participants
|
35 Participants
n=667 Participants
|
8874 Participants
n=12 Participants
|
|
Age, Customized
>=65
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
219 Participants
n=42 Participants
|
219 Participants
n=42 Participants
|
346 Participants
n=42 Participants
|
116 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
984 Participants
n=12 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
136 Participants
n=8 Participants
|
40 Participants
n=8 Participants
|
37 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
1227 Participants
n=42 Participants
|
1117 Participants
n=42 Participants
|
1635 Participants
n=42 Participants
|
518 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
69 Participants
n=24 Participants
|
22 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
43 Participants
n=44 Participants
|
36 Participants
n=667 Participants
|
5203 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
107 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
39 Participants
n=24 Participants
|
44 Participants
n=42 Participants
|
1151 Participants
n=42 Participants
|
1039 Participants
n=42 Participants
|
1554 Participants
n=42 Participants
|
509 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
60 Participants
n=24 Participants
|
53 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
4862 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
72 Participants
n=42 Participants
|
84 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
197 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
89 Participants
n=42 Participants
|
71 Participants
n=42 Participants
|
96 Participants
n=42 Participants
|
45 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
325 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
17 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
110 Participants
n=42 Participants
|
112 Participants
n=42 Participants
|
172 Participants
n=42 Participants
|
46 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
7 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
551 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
207 Participants
n=4 Participants
|
208 Participants
n=21 Participants
|
207 Participants
n=8 Participants
|
65 Participants
n=8 Participants
|
69 Participants
n=24 Participants
|
65 Participants
n=42 Participants
|
2010 Participants
n=42 Participants
|
1704 Participants
n=42 Participants
|
2612 Participants
n=42 Participants
|
889 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
115 Participants
n=24 Participants
|
63 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
35 Participants
n=44 Participants
|
33 Participants
n=667 Participants
|
8344 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
82 Participants
n=42 Participants
|
138 Participants
n=42 Participants
|
143 Participants
n=42 Participants
|
21 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
402 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
54 Participants
n=42 Participants
|
52 Participants
n=42 Participants
|
76 Participants
n=42 Participants
|
21 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
229 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
117 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
43 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
1002 Participants
n=42 Participants
|
1140 Participants
n=42 Participants
|
1413 Participants
n=42 Participants
|
316 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
87 Participants
n=24 Participants
|
40 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
4527 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
126 Participants
n=8 Participants
|
40 Participants
n=8 Participants
|
33 Participants
n=24 Participants
|
39 Participants
n=42 Participants
|
1357 Participants
n=42 Participants
|
992 Participants
n=42 Participants
|
1740 Participants
n=42 Participants
|
701 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
42 Participants
n=24 Participants
|
33 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
37 Participants
n=44 Participants
|
28 Participants
n=667 Participants
|
5439 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
10 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
99 Participants
n=12 Participants
|
|
Race
White
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
207 Participants
n=4 Participants
|
208 Participants
n=21 Participants
|
207 Participants
n=8 Participants
|
65 Participants
n=8 Participants
|
69 Participants
n=24 Participants
|
65 Participants
n=42 Participants
|
2010 Participants
n=42 Participants
|
1704 Participants
n=42 Participants
|
2612 Participants
n=42 Participants
|
889 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
115 Participants
n=24 Participants
|
63 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
35 Participants
n=44 Participants
|
33 Participants
n=667 Participants
|
8344 Participants
n=12 Participants
|
|
Race
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
110 Participants
n=42 Participants
|
112 Participants
n=42 Participants
|
172 Participants
n=42 Participants
|
46 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
7 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
551 Participants
n=12 Participants
|
|
Race
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
89 Participants
n=42 Participants
|
71 Participants
n=42 Participants
|
96 Participants
n=42 Participants
|
45 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
325 Participants
n=12 Participants
|
|
Race
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
72 Participants
n=42 Participants
|
84 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
197 Participants
n=12 Participants
|
|
Race
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
17 Participants
n=12 Participants
|
|
Race
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
82 Participants
n=42 Participants
|
138 Participants
n=42 Participants
|
143 Participants
n=42 Participants
|
21 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
402 Participants
n=12 Participants
|
|
Race
Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
54 Participants
n=42 Participants
|
52 Participants
n=42 Participants
|
76 Participants
n=42 Participants
|
21 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
229 Participants
n=12 Participants
|
|
Age Continous
|
43.8 years
STANDARD_DEVIATION 14.42 • n=5 Participants
|
38.9 years
STANDARD_DEVIATION 11.11 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 11.83 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 15.21 • n=4 Participants
|
42.7 years
STANDARD_DEVIATION 15.59 • n=21 Participants
|
41.7 years
STANDARD_DEVIATION 14.38 • n=8 Participants
|
43.5 years
STANDARD_DEVIATION 15.51 • n=8 Participants
|
44.8 years
STANDARD_DEVIATION 16.70 • n=24 Participants
|
44.0 years
STANDARD_DEVIATION 17.43 • n=42 Participants
|
45.4 years
STANDARD_DEVIATION 14.61 • n=42 Participants
|
46.7 years
STANDARD_DEVIATION 14.59 • n=42 Participants
|
46.1 years
STANDARD_DEVIATION 14.89 • n=42 Participants
|
44.8 years
STANDARD_DEVIATION 15.09 • n=36 Participants
|
14.0 years
STANDARD_DEVIATION 2.83 • n=36 Participants
|
10.9 years
STANDARD_DEVIATION 4.14 • n=24 Participants
|
12.2 years
STANDARD_DEVIATION 3.36 • n=135 Participants
|
31.0 years
STANDARD_DEVIATION 3.46 • n=136 Participants
|
28.9 years
STANDARD_DEVIATION 5.87 • n=44 Participants
|
28.3 years
STANDARD_DEVIATION 6.02 • n=667 Participants
|
44.7 years
STANDARD_DEVIATION 15.51 • n=12 Participants
|
PRIMARY outcome
Timeframe: Through Day 29Population: Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately
Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=2609 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=2614 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=1272 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
n=74 Participants
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
n=72 Participants
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
n=73 Participants
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
n=1329 Participants
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
n=2 Participants
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
n=129 Participants
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
n=71 Participants
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
n=2 Participants
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
n=43 Participants
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
n=35 Participants
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3]
|
97 Participants
|
31 Participants
|
19 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
14 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Through Day 4Population: Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately.
Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=2609 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=2614 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=1272 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
n=74 Participants
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
n=72 Participants
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
n=73 Participants
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
n=1329 Participants
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
n=2 Participants
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
n=129 Participants
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
n=71 Participants
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
n=2 Participants
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
n=43 Participants
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
n=35 Participants
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Infusion-related Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
|
2 Participants
|
4 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through Day 29Population: Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately.
Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=2609 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=2614 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=1272 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
n=74 Participants
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
n=72 Participants
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
n=73 Participants
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
n=1329 Participants
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
n=2 Participants
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
n=129 Participants
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
n=71 Participants
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
n=2 Participants
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
n=43 Participants
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
n=35 Participants
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Hypersensitivity Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 7Population: All randomized participants in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This pooled modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Primary: Phase 1, Phase 2
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=232 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=219 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=220 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Day 7, as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph1, Ph2)
|
-1.32 log10 copies/mL
Standard Deviation 1.047
|
-1.65 log10 copies/mL
Standard Deviation 0.977
|
-1.67 log10 copies/mL
Standard Deviation 1.157
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo)
|
3.2 Percentage of Participants
Interval 2.1 to 4.7
|
1.0 Percentage of Participants
Interval 0.4 to 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Primary: Phase 3 (Cohort 1)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1341 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1355 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1 - 2.4g vs Placebo)
|
4.6 Percentage of Participants
Interval 3.6 to 5.9
|
1.3 Percentage of Participants
Interval 0.8 to 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Nominal Sampling Day 28Population: The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Phase 3 Cohort 2 \[Nominal Sampling Time\] = \[Clinical Study Time (Visit Day - 1)\]
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=129 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=71 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2)
Day 0: End of Infusion
|
402 mg/L
Standard Deviation 196
|
710 mg/L
Standard Deviation 275
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2)
Nominal Sampling Day 28
|
108 mg/L
Standard Deviation 60.1
|
198 mg/L
Standard Deviation 78.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=680 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=673 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 1.2g vs Placebo)
|
14.0 Days
Interval 13.0 to 16.0
|
10.0 Days
Interval 9.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 (Cohort 1)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1197 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1214 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 2.4g vs Placebo)
|
14.0 Days
95% Confidence Interval 13.0 • Interval 13.0 to 15.0
|
10.0 Days
95% Confidence Interval 10.0 • Interval 10.0 to 11.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 4 thru Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 (Cohort 1)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=735 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=748 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 1.2g vs. Placebo)
|
5 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 4 Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 (Cohort 1)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1340 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1351 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 2.4g vs. Placebo)
|
46 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5, Day 7, Day 15, Day 29Population: Participants analyzed are part of modified Full Analysis Set (mFAS) and have documented status at baseline. Next Phase 2 participants included the next 524 participants randomized to Phase 2 subsequent to the first 275 symptomatic participants randomized in Phase 1 / 2
Next Phase 2 Symptomatic
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=151 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=145 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=146 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs (Next Phase 2 Cohort)
Day 7
|
-2.54 log10 copies/mL
Standard Error 0.13
|
-2.79 log10 copies/mL
Standard Error 0.13
|
-3.08 log10 copies/mL
Standard Error 0.13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs (Next Phase 2 Cohort)
Day 5
|
-1.79 log10 copies/mL
Standard Error 0.14
|
-2.33 log10 copies/mL
Standard Error 0.14
|
-2.28 log10 copies/mL
Standard Error 0.14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs (Next Phase 2 Cohort)
Day 15
|
-4.56 log10 copies/mL
Standard Error 0.14
|
-4.67 log10 copies/mL
Standard Error 0.14
|
-4.58 log10 copies/mL
Standard Error 0.14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs (Next Phase 2 Cohort)
Day 29
|
-5.42 log10 copies/mL
Standard Error 0.10
|
-5.60 log10 copies/mL
Standard Error 0.10
|
-5.45 log10 copies/mL
Standard Error 0.10
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: All randomized participants pooled in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Phase 1, Phase 2
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=232 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=219 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=220 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Post-baseline Study Days (Ph1, Ph2)
TWA Change from BL: Day 1 to Day 5
|
-0.93 log10 copies/mL
Standard Error 0.07
|
-1.23 log10 copies/mL
Standard Error 0.07
|
-1.25 log10 copies/mL
Standard Error 0.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Post-baseline Study Days (Ph1, Ph2)
TWA Change from BL: Day 1 to Day 7
|
-1.35 log10 copies/mL
Standard Error 0.07
|
-1.68 log10 copies/mL
Standard Error 0.08
|
-1.72 log10 copies/mL
Standard Error 0.08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Post-baseline Study Days (Ph1, Ph2)
TWA Change from BL: Day 1 to Day 15
|
-2.57 log10 copies/mL
Standard Error 0.07
|
-2.93 log10 copies/mL
Standard Error 0.08
|
-2.96 log10 copies/mL
Standard Error 0.08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Post-baseline Study Days (Ph1, Ph2)
TWA Change from BL: Day 1 to Day 29
|
-3.74 log10 copies/mL
Standard Error 0.06
|
-3.97 log10 copies/mL
Standard Error 0.07
|
-4.03 log10 copies/mL
Standard Error 0.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: All randomized participants pooled in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Phase 1, Phase 2
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=232 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=219 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=220 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit Through Day 29 (Ph1, Ph2)
|
7.8 Percentage of Participants
Interval 4.7 to 12.0
|
3.2 Percentage of Participants
Interval 1.3 to 6.5
|
2.7 Percentage of Participants
Interval 1.0 to 5.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: All randomized participants pooled in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Phase 1, Phase 2
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=232 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=219 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=220 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥1 COVID-19 Related Hospitalization, Emergency Room, or Urgent Care Visit Through Day 29 (Ph1, Ph2)
|
4.7 Percentage of Participants
Interval 2.4 to 8.3
|
2.7 Percentage of Participants
Interval 1.0 to 5.9
|
2.3 Percentage of Participants
Interval 0.7 to 5.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Phase 2 asymptomatic cohort
Phase 2 Only
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=74 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=72 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=73 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only)
|
4.0 Days
Interval 2.0 to
Insufficient number of participants with events
|
NA Days
Insufficient number of participants with events
|
4.0 Days
Interval 2.0 to
Insufficient number of participants with events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1 - Placebo vs. 1.2 g IV
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 1.2g IV
|
51 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 (Cohort 1)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1341 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1355 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 2.4g IV
|
62 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Nominal Sampling Day 28Population: The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Secondary: Phase 1, Phase 2, Phase 3 (Cohort 1 and Cohort 3) - Symptomatic Participants \[Nominal Sampling Time\] = \[Clinical Study Time (Visit Day - 1)\]
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=18 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=20 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=218 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
n=237 Participants
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
n=3477 Participants
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
n=3477 Participants
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
n=881 Participants
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
n=22 Participants
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
n=37 Participants
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Concentration of REGN10933 + REGN10987 in Serum Over Time (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1 and Cohort 3)
Day 0: EOI
|
594 mg/L
Standard Deviation 276
|
1652 mg/L
Standard Deviation 928
|
701 mg/L
Standard Deviation 287
|
2142 mg/L
Standard Deviation 815
|
415 mg/L
Standard Deviation 178
|
669 mg/L
Standard Deviation 236
|
2239 mg/L
Standard Deviation 740
|
305 mg/L
Standard Deviation 80.8
|
536 mg/L
Standard Deviation 165
|
—
|
—
|
—
|
—
|
|
Concentration of REGN10933 + REGN10987 in Serum Over Time (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1 and Cohort 3)
Day 28
|
141 mg/L
Standard Deviation 97.5
|
384 mg/L
Standard Deviation 143
|
142 mg/L
Standard Deviation 62.5
|
453 mg/L
Standard Deviation 179
|
85.1 mg/L
Standard Deviation 36.9
|
143 mg/L
Standard Deviation 55.1
|
463 mg/L
Standard Deviation 166
|
63.7 mg/L
Standard Deviation 25.9
|
119 mg/L
Standard Deviation 31.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Phase 1 Only
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=45 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933+REGN10987 (Phase 1)
2.4g IV
|
689 mg/L
Standard Deviation 391
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933+REGN10987 (Phase 1)
8.0g IV
|
1805 mg/L
Standard Deviation 720
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Phase 1 Only
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=45 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933+REGN10987 (Phase 1)
2.4g IV
|
27.7 Days
Interval 0.0847 to 28.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933+REGN10987 (Phase 1)
8.0g IV
|
0.0854 Days
Interval 0.0431 to 2.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Phase 1 Only
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=45 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to Day 28 Concentration (AUC 0-28) for REGN10933+REGN10987 (Phase 1)
2.4g IV
|
7158 day*milligram/Liter
Standard Deviation 4255
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to Day 28 Concentration (AUC 0-28) for REGN10933+REGN10987 (Phase 1)
8.0g IV
|
19084 day*milligram/Liter
Standard Deviation 5172
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Pooled participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Phase 1, Phase 2, Phase 3 (Cohort 1) - Pooled Symptomatic Participants
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=2609 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1935 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=3087 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
n=1272 Participants
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1)
|
17 Participants
|
29 Participants
|
20 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=123 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=64 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
n=39 Participants
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
n=33 Participants
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph3 Cohort 2 - Cohort 3)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Pooled participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Phase 1, Phase 2, Phase 3 (Cohort 1) - Pooled Symptomatic Participants
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=2609 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1934 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=3084 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
n=1272 Participants
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity as Measured by ADA to REGN10987 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1)
|
59 Participants
|
56 Participants
|
54 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=123 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=64 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
n=39 Participants
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
n=33 Participants
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity as Measured by ADA to REGN10987 (Ph3 Cohort 2 and Cohort 3)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants (TE\&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=123 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=64 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
n=39 Participants
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
n=33 Participants
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity as Measured by Neutralizing Antibodies (NAbs) to REGN10933 (Ph3 Cohort 2, Ph3 Cohort 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Participants will be analyzed according to the treatment actually received.
Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants (TE\&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=123 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=64 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
n=39 Participants
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
n=33 Participants
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity as Measured by NAbs to REGN10987 (Ph3 Cohort 2 - Cohort 3)
|
0 Participants
|
1 Participants
|
0 Participants
|
00 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants \<18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Phase 3 (Cohort 2)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=121 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=70 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Phase 3 Cohort 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: All randomized participants in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Phase 1, Phase 2 Medically-attended Visits include Hospitalizations, ER visits, Urgent Care Clinic visits, Outpatient/physician office/telemedicine visits
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=232 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=219 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=220 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit (Phase 1, Phase 2)
|
7.8 Percentage of Participants
Interval 4.7 to 12.0
|
3.2 Percentage of Participants
Interval 1.3 to 6.5
|
2.7 Percentage of Participants
Interval 1.0 to 5.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 (Cohort 1)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 1.2g IV
|
0.5 Percentage of Participants
Interval 0.1 to 1.4
|
0.4 Percentage of Participants
Interval 0.1 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1341 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1355 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 2.4g IV
|
1.1 Percentage of Participants
Interval 0.6 to 1.8
|
0.07 Percentage of Participants
Interval 0.0 to 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately.
Phase 1 and Phase 2
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=232 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=219 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=220 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total Number of COVID-19-related Medically-attended Visits (Phase 1 and Phase 2)
|
18 Number of Participants
|
7 Number of Participants
|
6 Number of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: The pharmacokinetics (PK) analysis pooled population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Phase 1 Only
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=45 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933 and REGN10987 (Phase 1 Only)
REGN10933
|
343 mg/L (milligram/Liters)
Standard Deviation 160
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933 and REGN10987 (Phase 1 Only)
REGN10987
|
353 mg/L (milligram/Liters)
Standard Deviation 233
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Though Day 29Population: The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Phase 1 Only
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=45 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Assessment of PK Parameter: Cmax-to-dose Ratio (Cmax/Dose) of REGN10933 and REGN10987 (Phase 1 Only)
REGN10933
|
0.286 mg/L/mg (milligram/Liter/milligram)
Standard Deviation 0.134
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of PK Parameter: Cmax-to-dose Ratio (Cmax/Dose) of REGN10933 and REGN10987 (Phase 1 Only)
REGN10987
|
0.294 mg/L/mg (milligram/Liter/milligram)
Standard Deviation 0.194
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Phase 1 Only
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=45 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933 and REGN10987 (Phase 1 Only)
REGN10933
|
0.0861 Day
Interval 0.0 to 14.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933 and REGN10987 (Phase 1 Only)
REGN10987
|
0.0861 Day
Interval 0.0 to 14.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Phase 1 Only - Tlast (Time of last quantifiable concentration)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=22 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to the Time of the Last Positive Concentration (AUClast) for REGN10933 - (Phase 1 Only)
REGN10933
|
27.7 ((day*mg/L)/mg)
Interval 0.0847 to 28.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to the Time of the Last Positive Concentration (AUClast) for REGN10933 - (Phase 1 Only)
REGN10987
|
27.7 ((day*mg/L)/mg)
Interval 13.0 to 28.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 4 Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
|
2.4 Percentage of Participants
Interval 1.4 to 3.8
|
0.7 Percentage of Participants
Interval 0.2 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 4 Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1340 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1351 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
|
3.4 Percentage of Participants
Interval 2.5 to 4.6
|
0.4 Percentage of Participants
Interval 0.1 to 0.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
|
6.8 Percentage of Participants
Interval 5.1 to 8.9
|
2.7 Percentage of Participants
Interval 1.7 to 4.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1341 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1355 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
|
8.1 Percentage of Participants
Interval 6.7 to 9.7
|
3.2 Percentage of Participants
Interval 2.3 to 4.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants \<18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Phase 3 (Cohort 2)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=121 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=70 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Phase 3 Cohort 2)
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Hospitalization
|
3.1 Percentage of Participants
Interval 2.0 to 4.6
|
0.8 Percentage of Participants
Interval 0.3 to 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Emergency Room
|
1.3 Percentage of Participants
Interval 0.6 to 2.4
|
0.3 Percentage of Participants
Interval 0.0 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Urgent Care
|
0.7 Percentage of Participants
Interval 0.2 to 1.6
|
0.1 Percentage of Participants
Interval 0.0 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Physician office visit/Telemedicine
|
1.6 Percentage of Participants
Interval 0.8 to 2.8
|
1.4 Percentage of Participants
Interval 0.7 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1341 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1355 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Hospitalization
|
4.4 Percentage of Participants
Interval 3.4 to 5.6
|
1.3 Percentage of Participants
Interval 0.7 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Emergency Room
|
1.2 Percentage of Participants
Interval 0.7 to 1.9
|
0.7 Percentage of Participants
Interval 0.3 to 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Urgent Care
|
0.5 Percentage of Participants
Interval 0.2 to 1.1
|
0.2 Percentage of Participants
Interval 0.0 to 0.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Physician office visit/Telemedicine
|
1.8 Percentage of Participants
Interval 1.1 to 2.7
|
1.0 Percentage of Participants
Interval 0.5 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants \<18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Phase 3 (Cohort 2)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=121 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=70 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total Number of COVID-19-related Medically-attended Visits by Type of Visit Through Day 29 (Phase 3 Cohort 2)
Emergency Room
|
0 Medically-Attended Visit
|
1 Medically-Attended Visit
|
0 Medically-Attended Visit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Total Number of COVID-19-related Medically-attended Visits by Type of Visit Through Day 29 (Phase 3 Cohort 2)
Outpatient/Telemedicine
|
0 Medically-Attended Visit
|
1 Medically-Attended Visit
|
1 Medically-Attended Visit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
|
3.2 Cumulative Incidence Percentage
Interval 2.2 to 4.8
|
1.0 Cumulative Incidence Percentage
Interval 0.5 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1341 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1355 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
|
4.6 Cumulative Incidence Percentage
Interval 3.6 to 5.9
|
1.3 Cumulative Incidence Percentage
Interval 0.8 to 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
|
4.6 Cumulative Incidence Percentage
Interval 3.3 to 6.3
|
1.2 Cumulative Incidence Percentage
Interval 0.6 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1341 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1355 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
|
5.8 Cumulative Incidence Percentage
Interval 4.7 to 7.2
|
2.0 Cumulative Incidence Percentage
Interval 1.4 to 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
|
6.9 Cumulative Incidence Percentage
Interval 5.2 to 8.9
|
2.7 Cumulative Incidence Percentage
Interval 1.8 to 4.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1341 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1355 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
|
8.2 Cumulative Incidence Percentage
Interval 6.8 to 9.8
|
3.2 Cumulative Incidence Percentage
Interval 2.4 to 4.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
|
2.1 Percentage of Participants
Interval 1.2 to 3.5
|
0.5 Percentage of Participants
Interval 0.1 to 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1341 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1355 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
|
3.6 Percentage of Participants
Interval 2.7 to 4.7
|
1.0 Percentage of Participants
Interval 0.5 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: by Day 29, Day 120, and Day 169Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 1.2g
by Day 29
|
0.1 Percentage of Participants
Interval 0.0 to 0.7
|
0.1 Percentage of Participants
Interval 0.0 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 1.2g
by Day 120
|
0.1 Percentage of Participants
Interval 0.0 to 0.7
|
0.1 Percentage of Participants
Interval 0.0 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 1.2g
by Day 169
|
0.1 Percentage of Participants
Interval 0.0 to 0.7
|
0.1 Percentage of Participants
Interval 0.0 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: by Day 29, Day 120, and Day 169Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1 Placebo vs. 2.4g IV
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1341 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1355 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 2.4g
by Day 29
|
0.2 Percentage of Participants
Interval 0.0 to 0.7
|
0.07 Percentage of Participants
Interval 0.0 to 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 2.4g
by Day 120
|
0.4 Percentage of Participants
Interval 0.1 to 0.9
|
0.07 Percentage of Participants
Interval 0.0 to 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 2.4g
by Day 169
|
0.1 Percentage of Participants
Interval 0.1 to 0.9
|
0.07 Percentage of Participants
Interval 0.0 to 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: In light of evolving information concerning SARS-CoV-2 infection, including the profile of viral load among patients and the adequacy of sampling methodologies, virologic efficacy endpoints and sampling methods were modified during the course of the study.
Next Phase 2 Only
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=150 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=142 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=145 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With High Viral Load at Each Visit - (Phase 2 Only)
Day 3
|
77.2 Percentage of Participants
Interval 69.2 to 84.0
|
67.4 Percentage of Participants
Interval 58.7 to 75.3
|
62.2 Percentage of Participants
Interval 53.5 to 70.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With High Viral Load at Each Visit - (Phase 2 Only)
Day 5
|
61.4 Percentage of Participants
Interval 52.8 to 69.5
|
47.0 Percentage of Participants
Interval 38.3 to 55.8
|
44.1 Percentage of Participants
Interval 35.6 to 52.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With High Viral Load at Each Visit - (Phase 2 Only)
Day 7
|
48.9 Percentage of Participants
Interval 40.4 to 57.5
|
31.3 Percentage of Participants
Interval 23.5 to 40.0
|
28.8 Percentage of Participants
Interval 21.2 to 37.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With High Viral Load at Each Visit - (Phase 2 Only)
Day 15
|
10.0 Percentage of Participants
Interval 4.9 to 17.6
|
5.1 Percentage of Participants
Interval 1.7 to 11.5
|
4.2 Percentage of Participants
Interval 1.2 to 10.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With High Viral Load at Each Visit - (Phase 2 Only)
Day 29
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
2.0 Percentage of Participants
Interval 0.1 to 10.9
|
1.8 Percentage of Participants
Interval 0.0 to 9.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis. Therefore, data was not collected for this outcome measure. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Phase 1 Only
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline Up To Day 29Population: Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis. Therefore, data was not collected for this outcome measure. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Phase 1 Only
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline Up to Day 29Population: Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis. Therefore, data was not collected for this outcome measure. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Phase 1 Only
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up To Day 29Population: Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis. Therefore, data was not collected for this outcome measure. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Phase 1 Only
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 22Population: In light of evolving information concerning SARS-CoV-2 infection, including the profile of viral load among patients and the adequacy of sampling methodologies, virologic efficacy endpoints and sampling methods were modified during the course of the study
Phase 1 Only
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 29Population: In light of evolving information concerning SARS-CoV-2 infection, including the profile of viral load among patients and the adequacy of sampling methodologies, virologic efficacy endpoints and sampling methods were modified during the course of the study
Phase 2 Only
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=57 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=49 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=51 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Viral Loads Below the Limit of Detection at Each Visit - (Phase 2 Only)
Day 0 (Baseline)
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral Loads Below the Limit of Detection at Each Visit - (Phase 2 Only)
Day 5
|
14 Number of Participants
|
15 Number of Participants
|
10 Number of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral Loads Below the Limit of Detection at Each Visit - (Phase 2 Only)
Day 7
|
18 Number of Participants
|
22 Number of Participants
|
14 Number of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral Loads Below the Limit of Detection at Each Visit - (Phase 2 Only)
Day 15
|
36 Number of Participants
|
39 Number of Participants
|
32 Number of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Viral Loads Below the Limit of Detection at Each Visit - (Phase 2 Only)
Day 29
|
48 Number of Participants
|
44 Number of Participants
|
36 Number of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants who were part of Phase 2 Asymptomatic modified Full Analysis Set (mFAS)
Phase 2 Only
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=22 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=14 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=17 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Symptoms Consistent With COVID-19 (Phase 2 Only)
|
12.6 Days
Standard Deviation 9.27
|
13.1 Days
Standard Deviation 9.34
|
14.4 Days
Standard Deviation 10.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Phase 2 asymptomatic cohort
Phase 2 Only
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=57 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=49 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=51 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only)
|
3.0 Days
Interval 1.0 to 9.0
|
2.5 Days
Interval 1.0 to
Inadequate number of events to reach upper limit
|
4.0 Days
Interval 2.0 to
Inadequate number of events to reach upper limit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: All pooled randomized participants in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Phase 1, Phase 2
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=81 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=73 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=74 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Admitted to a Hospital Due to COVID-19 (Phase 1, Phase 2)
|
1 Number Participants
Interval 0.0 to 6.7
|
0 Number Participants
Interval 0.0 to 0.0
|
0 Number Participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: In light of evolving information concerning SARS-CoV-2 infection, including the profile of viral load among patients and the adequacy of sampling methodologies, virologic efficacy endpoints and sampling methods were modified during the course of the study
Phase 1 Only
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 29Population: Phase 2 asymptomatic cohort
Phase 2 Asymptomatic
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=73 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=74 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=75 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With All-cause Mortality (Phase 2 Asymptomatic)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 169Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1 (1.2g IV)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo)
|
NA Days
Unable to calculate due to too few events
|
NA Days
Unable to calculate due to too few events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 169Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1 (2.4g IV)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1341 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1355 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to All-cause Death (Ph3 Cohort 1- 2.4g vs Placebo)
|
NA Days
Unable to calculate due to too few events
|
NA Days
Unable to calculate due to too few events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: There were no deaths in this cohort. Phase 3 Cohort 2 data was not analyzed for this endpoint as there were no deaths.
Phase 3 (Cohort 2)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=121 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=70 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to All-cause Death (Phase 3 Cohort 2)
|
0 Days
|
0 Days
|
0 Days
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 1.2g vs Placebo)
|
0.3 Percentage of Participants
Interval 0.0 to 1.0
|
0.1 Percentage of Participants
Interval 0.0 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1341 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1355 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 2.4g vs Placebo)
|
0.4 Proportion of Participants
Interval 0.2 to 1.0
|
0.0007 Proportion of Participants
Interval 0.0 to 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: There were 0 events in this endpoint. Phase 3 Cohort 2 data was not analyzed for this endpoint as there were 0 events in in this cohort
Phase 3 (Cohort 2)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=121 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=70 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Phase 3 Cohort 2)
|
0 Percent
|
0 Percent
|
0 Percent
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 1.2g vs. Placebo)
Day 7
|
-3.14 log10 copies/mL
Standard Deviation 1.964
|
-3.90 log10 copies/mL
Standard Deviation 2.027
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 1.2g vs. Placebo)
Day 15
|
-5.01 log10 copies/mL
Standard Deviation 2.068
|
-5.37 log10 copies/mL
Standard Deviation 2.098
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 1.2g vs. Placebo)
Day 29
|
-6.06 log10 copies/mL
Standard Deviation 1.976
|
-6.32 log10 copies/mL
Standard Deviation 2.107
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1341 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1355 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 2.4g vs. Placebo)
Day 7
|
-3.01 log10 copies/mL
Standard Deviation 1.951
|
-3.89 log10 copies/mL
Standard Deviation 1.940
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 2.4g vs. Placebo)
Day 15
|
-5.02 log10 copies/mL
Standard Deviation 2.034
|
-5.44 log10 copies/mL
Standard Deviation 2.104
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 2.4g vs. Placebo)
Day 29
|
-6.08 log10 copies/mL
Standard Deviation 1.943
|
-6.19 log10 copies/mL
Standard Deviation 1.968
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 29Population: Participants \<18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Phase 3 Cohort 2
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=121 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=70 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 2)
Day 7
|
-1.95 log10 copies/mL
Standard Deviation NA
Inadequate number of events to calculate standard deviation
|
-4.47 log10 copies/mL
Standard Deviation 2.522
|
-5.23 log10 copies/mL
Standard Deviation 1.985
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 2)
Day 15
|
-4.50 log10 copies/mL
Standard Deviation NA
Inadequate number of events to calculate standard deviation
|
-6.10 log10 copies/mL
Standard Deviation 2.058
|
-6.83 log10 copies/mL
Standard Deviation 1.940
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 2)
Day 29
|
-4.50 log10 copies/mL
Standard Deviation NA
Inadequate number of events to calculate standard deviation
|
-6.50 log10 copies/mL
Standard Deviation 1.930
|
-7.06 log10 copies/mL
Standard Deviation 1.724
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 7Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 (Cohort 1)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=571 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=603 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=608 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 1)
|
-1.46 log10 copies/mL
Standard Deviation 1.220
|
-2.02 log10 copies/mL
Standard Deviation 1.021
|
-2.05 log10 copies/mL
Standard Deviation 1.079
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 7Population: Participants \<18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Phase 3 (Cohort 2)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=117 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=62 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 2)
|
-0.97 log10 copies/mL
Standard Deviation NA
Unable to calculate SD due to number of participants analyzed
|
-2.49 log10 copies/mL
Standard Deviation 1.413
|
-2.94 log10 copies/mL
Standard Deviation 1.435
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0, Day 5, Day 7, Day 15, Day 29Population: Participants analyzed are part of modified Full Analysis Set (mFAS) and have documented status at baseline. Next Phase 2 participants included the next 524 participants randomized to Phase 2 subsequent to the first 275 symptomatic participants randomized in Phase 1 / 2
Next Phase 2 Symptomatic
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=150 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=142 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=145 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With Viral Loads Below the Lower Limit of Detection at Each Visit - (Phase 2 Only)
Day 0 (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With Viral Loads Below the Lower Limit of Detection at Each Visit - (Phase 2 Only)
Day 5
|
20 Participants
|
21 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With Viral Loads Below the Lower Limit of Detection at Each Visit - (Phase 2 Only)
Day 7
|
27 Participants
|
22 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With Viral Loads Below the Lower Limit of Detection at Each Visit - (Phase 2 Only)
Day 15
|
59 Participants
|
59 Participants
|
60 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With Viral Loads Below the Lower Limit of Detection at Each Visit - (Phase 2 Only)
Day 29
|
43 Participants
|
42 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0, Day 5, Day 7, Day 15, Day 29Population: Participants analyzed are part of modified Full Analysis Set (mFAS) and have documented status at baseline. Next Phase 2 participants included the next 524 participants randomized to Phase 2 subsequent to the first 275 symptomatic participants randomized in Phase 1 / 2
Next Phase 2 Symptomatic
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=150 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=142 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=145 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With Viral Loads Below the Lower Limit of Quantitation at Each Visit - (Phase 2 Only)
Day 0 (Baseline)
|
6 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With Viral Loads Below the Lower Limit of Quantitation at Each Visit - (Phase 2 Only)
Day 5
|
25 Participants
|
26 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With Viral Loads Below the Lower Limit of Quantitation at Each Visit - (Phase 2 Only)
Day 7
|
38 Participants
|
38 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With Viral Loads Below the Lower Limit of Quantitation at Each Visit - (Phase 2 Only)
Day 15
|
68 Participants
|
72 Participants
|
74 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants With Viral Loads Below the Lower Limit of Quantitation at Each Visit - (Phase 2 Only)
Day 29
|
50 Participants
|
46 Participants
|
51 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 (Cohort 1)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=62 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 1.2g IV
|
10.0 Days
Standard Deviation 7.16
|
7.0 Days
Standard Deviation 8.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 (Cohort 1)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=24 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 2.4g IV
|
8.4 Days
Standard Deviation 6.74
|
7.0 Days
Standard Deviation 8.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants \<18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease. No participants were hospitalized, therefore no hospitalizations days took place.
Phase 3 (Cohort 2)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Day 29Population: Phase 2 asymptomatic cohort. No participants were hospitalized, therefore no hospitalizations days took place.
Phase 2 Only
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 (Cohort 1)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=748 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=736 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 1.2g IV
|
0.9 Proportion of Participants
Interval 0.4 to 1.9
|
0.4 Proportion of Participants
Interval 0.1 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 (Cohort 1)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1341 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=1355 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 2.4g IV
|
1.3 Percentage of Participants
Interval 0.8 to 2.1
|
0.4 Percentage of Participants
Interval 0.2 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants \<18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Phase 3 (Cohort 2)
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=121 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=70 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants analyzed are part of modified Full Analysis Set (mFAS) and have documented status at baseline. Next Phase 2 participants included the next 524 participants randomized to Phase 2 subsequent to the first 275 symptomatic participants randomized in Phase 1 / 2
Next Phase 2
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=150 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=142 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=145 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Next Phase 2) #87
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=51 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=20 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 1.2g
|
1.1 Number of Visits
Standard Deviation 0.27
|
1.2 Number of Visits
Standard Deviation 0.52
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Phase 3 Cohort 1
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=109 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=43 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 2.4g
|
1.2 Number of Visits
Standard Deviation 0.41
|
1.0 Number of Visits
Standard Deviation 0.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 29Population: Participants \<18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Phase 3 Cohort 2
Outcome measures
| Measure |
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo)
n=1 Participants
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV)
n=121 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
|
Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV)
n=70 Participants
Pooled analysis of Phases 1, 2, \& 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
|
Phase 2 Asymptomatic (Placebo)
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (2.4g IV)
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic (8.0g IV)
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Cohort 1 (1.2g IV) Symptomatic
Phase 3 Cohort 1(1.2g IV) Symptomatic Participants
|
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
|
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
|
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
|
Phase 3 Cohort 3 Pregnant (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
|
Phase 3 Cohort 3 Pregnant (1.2g IV)
Phase 3 Cohort 3 Pregnant (1.2g IV)
|
Phase 3 Cohort 3 Pregnant (2.4g IV)
Phase 3 Cohort 3 Pregnant (2.4g IV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 2)
|
1.0 Number of Visits
Standard Deviation 0.0
|
1.0 Number of Visits
Standard Deviation NA
too small a number of data points to calculate
|
1.0 Number of Visits
Standard Deviation 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1 Symptomatic Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Symptomatic R10933+R10987 2.4g IV
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Symptomatic R10933+R10987 8.0g IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2 Symptomatic Placebo
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 2 Symptomatic R10933+R10987 2.4g IV
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 2 Symptomatic R10933+R10987 8.0g IV
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 2 Asymptomatic Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2 Asymptomatic R10933+R10987 2.4g IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2 Asymptomatic R10933+R10987 8.0g IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 3 Age>=18 Placebo
Serious events: 103 serious events
Other events: 16 other events
Deaths: 11 deaths
Phase 3 Age>=18 R10933+R10987 1.2g IV
Serious events: 39 serious events
Other events: 16 other events
Deaths: 2 deaths
Phase 3 Age>=18 R10933+R10987 2.4g IV
Serious events: 52 serious events
Other events: 19 other events
Deaths: 4 deaths
Phase 3 Age>=18 R10933+R10987 8.0g IV
Serious events: 19 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 3 Age<18 Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 3 Age<18 R10933+R10987 1.2g IV
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 3 Age<18 R10933+R10987 2.4g IV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 3 Pregnant Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 3 Pregnant R10933+R10987 1.2g IV
Serious events: 11 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 3 Pregnant R10933+R10987 2.4g IV
Serious events: 7 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Symptomatic Placebo
n=24 participants at risk
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 1 Symptomatic R10933+R10987 2.4g IV
n=22 participants at risk
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 1 Symptomatic R10933+R10987 8.0g IV
n=23 participants at risk
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic Placebo
n=238 participants at risk
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic R10933+R10987 2.4g IV
n=236 participants at risk
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic R10933+R10987 8.0g IV
n=237 participants at risk
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Asymptomatic Placebo
n=73 participants at risk
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic R10933+R10987 2.4g IV
n=74 participants at risk
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic R10933+R10987 8.0g IV
n=75 participants at risk
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Age>=18 Placebo
n=2347 participants at risk
Placebo of R10933 + R10987 Participants \>=18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18 R10933+R10987 1.2g IV
n=2130 participants at risk
1.2g of R10933 + R10987 Participants \>=18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18 R10933+R10987 2.4g IV
n=3157 participants at risk
2.4g of R10933 + R10987 Participants \>=18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18 R10933+R10987 8.0g IV
n=1012 participants at risk
8.0g of R10933 + R10987 Participants \>=18 with COVID-19, not pregnant at randomization
|
Phase 3 Age<18 Placebo
n=2 participants at risk
Placebo of R10933 + R10987 Participants \<18 with COVID-19, not pregnant at randomization
|
Phase 3 Age<18 R10933+R10987 1.2g IV
n=129 participants at risk
1.2g of R10933 + R10987 Participants \<18 with COVID-19
|
Phase 3 Age<18 R10933+R10987 2.4g IV
n=71 participants at risk
2.4g of R10933 + R10987 Participants \<18 with COVID-19
|
Phase 3 Pregnant Placebo
n=2 participants at risk
Placebo of R10933 + R10987 Participants who are pregnant with COVID-19
|
Phase 3 Pregnant R10933+R10987 1.2g IV
n=43 participants at risk
1.2g of R10933 + R10987 Participants who are pregnant with COVID-19
|
Phase 3 Pregnant R10933+R10987 2.4g IV
n=35 participants at risk
2.4g of R10933 + R10987 Participants who are pregnant with COVID-19
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic stenosis
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.42%
1/237 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Breast abscess
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
COVID-19
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.42%
1/238 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.85%
20/2347 • Number of events 21 • From first dose to end of study (approx. 8 months)
|
0.14%
3/2130 • Number of events 3 • From first dose to end of study (approx. 8 months)
|
0.29%
9/3157 • Number of events 9 • From first dose to end of study (approx. 8 months)
|
0.49%
5/1012 • Number of events 5 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.85%
2/236 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.81%
19/2347 • Number of events 21 • From first dose to end of study (approx. 8 months)
|
0.23%
5/2130 • Number of events 5 • From first dose to end of study (approx. 8 months)
|
0.19%
6/3157 • Number of events 6 • From first dose to end of study (approx. 8 months)
|
0.49%
5/1012 • Number of events 5 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
2.9%
1/35 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Abscess
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.09%
2/2347 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Kidney infection
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Abscess neck
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.42%
1/236 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Cardiac disorders
Arrhythmia neonatal
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Cardiac disorders
Mitral valve calcification
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Congenital, familial and genetic disorders
Anal atresia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
2.3%
1/43 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Congenital, familial and genetic disorders
Craniosynostosis
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
2.9%
1/35 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
|
Congenital, familial and genetic disorders
Foetal malformation
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
2.9%
1/35 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
|
Congenital, familial and genetic disorders
Macrocephaly
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
2.3%
1/43 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
2.3%
1/43 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
4.5%
1/22 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
4.5%
1/22 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
General disorders
Death
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
General disorders
Fever neonatal
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
General disorders
Impaired healing
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.09%
2/2347 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 3 • From first dose to end of study (approx. 8 months)
|
0.06%
2/3157 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
General disorders
Pyrexia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia neonatal
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
2.9%
1/35 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Lung abscess
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Metapneumovirus pneumonia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.78%
1/129 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.84%
2/238 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.81%
19/2347 • Number of events 20 • From first dose to end of study (approx. 8 months)
|
0.23%
5/2130 • Number of events 5 • From first dose to end of study (approx. 8 months)
|
0.19%
6/3157 • Number of events 6 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.06%
2/3157 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Sepsis
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.09%
2/2347 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.06%
2/3157 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Investigations
Continuous glucose monitoring
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
2.3%
1/43 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.09%
2/2347 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
2.3%
1/43 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.42%
1/236 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.13%
3/2347 • Number of events 3 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Nervous system disorders
Hyporesponsive to stimuli
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Nervous system disorders
Migraine
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Pregnancy, puerperium and perinatal conditions
Abnormal labour
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
2.9%
1/35 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
2.3%
1/43 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Pregnancy, puerperium and perinatal conditions
Foetal growth restriction
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
2.9%
1/35 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
7.0%
3/43 • Number of events 3 • From first dose to end of study (approx. 8 months)
|
2.9%
1/35 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
2.3%
1/43 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
2.3%
1/43 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Pregnancy, puerperium and perinatal conditions
Preterm premature rupture of membranes
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
2.9%
1/35 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Psychiatric disorders
Depression
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Psychiatric disorders
Perinatal depression
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
2.3%
1/43 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.78%
1/129 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
2.3%
1/43 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
2.9%
1/35 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.78%
1/129 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.21%
5/2347 • Number of events 5 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.06%
2/3157 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.42%
1/237 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.43%
10/2347 • Number of events 10 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.84%
2/238 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.26%
6/2347 • Number of events 6 • From first dose to end of study (approx. 8 months)
|
0.05%
1/2130 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.06%
2/3157 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.09%
2/2130 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.09%
2/2347 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.78%
1/129 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Vascular disorders
Hypertension
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.42%
1/238 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.42%
1/236 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.03%
1/3157 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
|
Vascular disorders
May-Thurner syndrome
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.04%
1/2347 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/43 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
Other adverse events
| Measure |
Phase 1 Symptomatic Placebo
n=24 participants at risk
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 1 Symptomatic R10933+R10987 2.4g IV
n=22 participants at risk
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 1 Symptomatic R10933+R10987 8.0g IV
n=23 participants at risk
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic Placebo
n=238 participants at risk
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic R10933+R10987 2.4g IV
n=236 participants at risk
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Symptomatic R10933+R10987 8.0g IV
n=237 participants at risk
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
|
Phase 2 Asymptomatic Placebo
n=73 participants at risk
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic R10933+R10987 2.4g IV
n=74 participants at risk
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 2 Asymptomatic R10933+R10987 8.0g IV
n=75 participants at risk
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
|
Phase 3 Age>=18 Placebo
n=2347 participants at risk
Placebo of R10933 + R10987 Participants \>=18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18 R10933+R10987 1.2g IV
n=2130 participants at risk
1.2g of R10933 + R10987 Participants \>=18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18 R10933+R10987 2.4g IV
n=3157 participants at risk
2.4g of R10933 + R10987 Participants \>=18 with COVID-19, not pregnant at randomization
|
Phase 3 Age>=18 R10933+R10987 8.0g IV
n=1012 participants at risk
8.0g of R10933 + R10987 Participants \>=18 with COVID-19, not pregnant at randomization
|
Phase 3 Age<18 Placebo
n=2 participants at risk
Placebo of R10933 + R10987 Participants \<18 with COVID-19, not pregnant at randomization
|
Phase 3 Age<18 R10933+R10987 1.2g IV
n=129 participants at risk
1.2g of R10933 + R10987 Participants \<18 with COVID-19
|
Phase 3 Age<18 R10933+R10987 2.4g IV
n=71 participants at risk
2.4g of R10933 + R10987 Participants \<18 with COVID-19
|
Phase 3 Pregnant Placebo
n=2 participants at risk
Placebo of R10933 + R10987 Participants who are pregnant with COVID-19
|
Phase 3 Pregnant R10933+R10987 1.2g IV
n=43 participants at risk
1.2g of R10933 + R10987 Participants who are pregnant with COVID-19
|
Phase 3 Pregnant R10933+R10987 2.4g IV
n=35 participants at risk
2.4g of R10933 + R10987 Participants who are pregnant with COVID-19
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.00%
0/3157 • From first dose to end of study (approx. 8 months)
|
0.00%
0/1012 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
2.3%
1/43 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
5.7%
2/35 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.84%
2/238 • Number of events 2 • From first dose to end of study (approx. 8 months)
|
0.42%
1/236 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.42%
1/237 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.68%
16/2347 • Number of events 16 • From first dose to end of study (approx. 8 months)
|
0.75%
16/2130 • Number of events 17 • From first dose to end of study (approx. 8 months)
|
0.38%
12/3157 • Number of events 12 • From first dose to end of study (approx. 8 months)
|
0.30%
3/1012 • Number of events 3 • From first dose to end of study (approx. 8 months)
|
50.0%
1/2 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
0.00%
0/71 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
2.3%
1/43 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
2.9%
1/35 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/24 • From first dose to end of study (approx. 8 months)
|
0.00%
0/22 • From first dose to end of study (approx. 8 months)
|
0.00%
0/23 • From first dose to end of study (approx. 8 months)
|
0.00%
0/238 • From first dose to end of study (approx. 8 months)
|
0.00%
0/236 • From first dose to end of study (approx. 8 months)
|
0.00%
0/237 • From first dose to end of study (approx. 8 months)
|
0.00%
0/73 • From first dose to end of study (approx. 8 months)
|
0.00%
0/74 • From first dose to end of study (approx. 8 months)
|
0.00%
0/75 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2347 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2130 • From first dose to end of study (approx. 8 months)
|
0.22%
7/3157 • Number of events 7 • From first dose to end of study (approx. 8 months)
|
0.10%
1/1012 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
0.00%
0/129 • From first dose to end of study (approx. 8 months)
|
1.4%
1/71 • Number of events 1 • From first dose to end of study (approx. 8 months)
|
0.00%
0/2 • From first dose to end of study (approx. 8 months)
|
7.0%
3/43 • Number of events 3 • From first dose to end of study (approx. 8 months)
|
0.00%
0/35 • From first dose to end of study (approx. 8 months)
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Phone: 8447346643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER