Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection (NCT NCT04811040)
NCT ID: NCT04811040
Last Updated: 2025-01-27
Results Overview
A treatment emergent SAE was defined as an event that, at any dose, resulted in the following: death; life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; a medically important event or reaction: such events may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes constituting SAEs. These events had an onset date on or after the study drug start date and prior to the last exposure date of long-acting (LA) regimen period for the LA regimen period analysis. The long acting regimen period included participants who were randomized and received at least one dose of the complete LA study drug regimen (ie, SC LEN + Teropavimab + Zinlirvimab).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Day 1 up to Week 26
Results posted on
2025-01-27
Participant Flow
Participants were enrolled at study sites in the United States.
124 participants were screened.
Participant milestones
| Measure |
Primary Cohort: Lenacapavir (LEN)+Teropavimab+Zinlirvimab 10 mg/kg
Participants received a loading dose of 600 milligram (mg) LEN orally on Day 1 and Day 2, along with 927 mg LEN as subcutaneous (SC) injection on Day 1. Thereafter, participants received 30 milligram per kilogram (mg/kg) teropavimab and then 10 mg/kg zinlirvimab as an intravenous (IV) infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Pilot Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Pilot Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
5
|
6
|
|
Overall Study
COMPLETED
|
8
|
9
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Primary Cohort: Lenacapavir (LEN)+Teropavimab+Zinlirvimab 10 mg/kg
Participants received a loading dose of 600 milligram (mg) LEN orally on Day 1 and Day 2, along with 927 mg LEN as subcutaneous (SC) injection on Day 1. Thereafter, participants received 30 milligram per kilogram (mg/kg) teropavimab and then 10 mg/kg zinlirvimab as an intravenous (IV) infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Pilot Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Pilot Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrew consent
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
Baseline characteristics by cohort
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=11 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Pilot Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=5 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Pilot Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=6 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
41 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
47 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
46 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
44 years
STANDARD_DEVIATION 11.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race/Ethnicity, Customized
Race · White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Other or More Than One Race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Week 26Population: The Safety Analysis Set for the LA regimen included all randomized participants who had received at least 1 dose of the complete LA study drug regimen (ie, SC LEN + Teropavimab + Zinlirvimab).
A treatment emergent SAE was defined as an event that, at any dose, resulted in the following: death; life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; a medically important event or reaction: such events may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes constituting SAEs. These events had an onset date on or after the study drug start date and prior to the last exposure date of long-acting (LA) regimen period for the LA regimen period analysis. The long acting regimen period included participants who were randomized and received at least one dose of the complete LA study drug regimen (ie, SC LEN + Teropavimab + Zinlirvimab).
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: The Full Analysis Set included all randomized participants who had received at least 1 dose of the complete LA study drug regimen (ie, SC LEN + Teropavimab + Zinlirvimab) without major protocol violation (defined as meeting exclusion criterion of having chronic hepatitis B virus infection).
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 26 was analyzed using the snapshot algorithm, which defined a participant's virologic outcome and included participants who had the last available on-treatment HIV-1 RNA \< 50 copies/mL in the Week 26 analysis window. Week 26 window was between Days 176 and 224 (inclusive).
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: Percentage of Participants With Human Immunodeficiency Virus- 1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 26 as Determined by the US Food and Drug Administration (FDA)-Defined Snapshot Algorithm
|
90.0 percentage of participants
Interval 55.5 to 99.7
|
90.0 percentage of participants
Interval 55.5 to 99.7
|
SECONDARY outcome
Timeframe: Week 26Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using the snapshot algorithm, which defined a participant's virologic outcome and included participants a) who had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 26 analysis window due to AE or death and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 26 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL. Week 26 window was between Days 176 and 224 (inclusive).
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm
|
0 percentage of participants
Interval 0.0 to 30.8
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
SECONDARY outcome
Timeframe: Week 26Population: Anti-teropavimab Immunogenicity Analysis Set included all randomized participants who had received at least 1 dose of study drug and have had at least 1 nonmissing value for anti-teropavimab evaluation.
Anti-teropavimab antibodies positive participants are participants with positive treatment-emergent anti-drug antibody.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: Percentage of Participants With Positive Anti-Teropavimab Antibodies
|
10.0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: Anti-zinlirvimab Immunogenicity Analysis Set included all randomized participants who had received at least 1 dose of study drug and have had at least 1 nonmissing value for anti- zinlirvimab evaluation.
Anti-zinlirvimab antibodies positive participants are participants with positive treatment-emergent anti-drug antibody.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: Percentage of Participants With Positive Anti-zinlirvimab Antibodies
|
20.0 percentage of participants
|
40.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 26Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 26
Week 26
|
-5 cells per microliter (cells/µL)
Standard Deviation 162.2
|
-25 cells per microliter (cells/µL)
Standard Deviation 241.6
|
|
Primary Cohort: Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 26
Baseline
|
1086 cells per microliter (cells/µL)
Standard Deviation 333.6
|
903 cells per microliter (cells/µL)
Standard Deviation 303.7
|
SECONDARY outcome
Timeframe: Day 1 up to Week 26Population: Participants in the Resistance Analysis Population included those who experienced virologic failure through Week 26.
Participants in the Resistance Analysis Population analyzed for this outcome included any participant who had received 1 dose of study drug, maintained their study drug regimen, and met one of the following virologic failure criteria: * Participants with HIV-1 RNA \>/= 200 copies/mL on 2 consecutive visits * Participants with HIV-1 RNA \>/= 200 copies/mL at study discontinuation or Week 26.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=1 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: Number of Participants Who Develop Treatment-Emergent Resistance to LEN, Teropavimab, and Zinlirvimab
Participants who developed resistance to LEN
|
—
|
1 Participants
|
|
Primary Cohort: Number of Participants Who Develop Treatment-Emergent Resistance to LEN, Teropavimab, and Zinlirvimab
Participants who developed resistance to Teropavimab
|
—
|
0 Participants
|
|
Primary Cohort: Number of Participants Who Develop Treatment-Emergent Resistance to LEN, Teropavimab, and Zinlirvimab
Participants who developed resistance to Zinlirvimab
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Week 26Population: Participants in the Safety Analysis Set for the LA regimen were analyzed.
TEAEs were those adverse events that began on or after the first dose date of study drug and prior to last exposure date of LA regimen from participants who prematurely discontinued study or completed study, or any adverse events led to premature study drug discontinuation.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
|
100 percentage of participants
|
90 percentage of participants
|
SECONDARY outcome
Timeframe: Predose and at End of Infusion (EOI) of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26Population: The Teropavimab PK Analysis Set included all randomized participants who had received at least 1 dose of study drug, and had at least 1 nonmissing teropavimab concentration value reported by the PK laboratory test.
AUC0-26 is defined as the concentration of drug over time from Week zero to Week 26.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: Pharmacokinetic (PK) Parameter: AUC0-26 of Teropavimab
|
31600 day* μg/mL
Standard Deviation 3750
|
30500 day* μg/mL
Standard Deviation 2270
|
SECONDARY outcome
Timeframe: Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26Population: The Zinlirvimab PK Analysis Set included all randomized participants who had received at least 1 dose of study drug, and had at least 1 nonmissing zinlirvimab concentration value reported by the PK laboratory test. Participants with available data were analyzed.
AUC0-26 is defined as the concentration of drug over time from Week zero to Week 26.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=9 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=9 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: AUC0-26 of Zinlirvimab
|
46100 day* μg/mL
Standard Deviation 4180
|
14800 day* μg/mL
Standard Deviation 2090
|
SECONDARY outcome
Timeframe: Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)Population: Participants in the Teropavimab PK Analysis Set were analyzed.
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: AUClast of Teropavimab
|
34400 day* μg/mL
Standard Deviation 5500
|
32900 day* μg/mL
Standard Deviation 3140
|
SECONDARY outcome
Timeframe: Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)Population: Participants in the Zinlirvimab PK Analysis Set with available data were analyzed.
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=9 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=9 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: AUClast of Zinlirvimab
|
54700 day* μg/mL
Standard Deviation 5290
|
17100 day* μg/mL
Standard Deviation 2640
|
SECONDARY outcome
Timeframe: Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)Population: The LEN PK Analysis Set included all randomized participants who had received at least 1 dose of study drug, and had at least 1 nonmissing LEN concentration value reported by the PK laboratory test. Participants with available data were analyzed.
T1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=9 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=8 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: T1/2 of LEN
|
69.8 day
Interval 55.1 to 140.0
|
65.8 day
Interval 33.9 to 99.3
|
SECONDARY outcome
Timeframe: Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)Population: Participants in the Teropavimab PK Analysis Set were analyzed.
T1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: T1/2 of Teropavimab
|
70.5 day
Interval 57.5 to 89.6
|
65.2 day
Interval 54.3 to 78.3
|
SECONDARY outcome
Timeframe: Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)Population: Participants in the Zinlirvimab PK Analysis Set with available data were analyzed.
T1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=9 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: T1/2 of Zinlirvimab
|
84.5 day
Interval 71.6 to 149.0
|
76.7 day
Interval 43.4 to 113.0
|
SECONDARY outcome
Timeframe: Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)Population: Participants in the Teropavimab PK Analysis Set were analyzed.
Cmax is defined as the maximum observed concentration of drug.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: Cmax of Teropavimab
|
1090 μg/mL
Standard Deviation 222
|
1090 μg/mL
Standard Deviation 160
|
SECONDARY outcome
Timeframe: Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)Population: Participants in the Zinlirvimab PK Analysis Set with available data were analyzed.
Cmax is defined as the maximum observed concentration of drug.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=9 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=9 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: Cmax of Zinlirvimab
|
1110 μg/mL
Standard Deviation 187
|
378 μg/mL
Standard Deviation 57.5
|
SECONDARY outcome
Timeframe: Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)Population: Participants in the Teropavimab PK Analysis Set were analyzed.
Tmax is defined as the time (observed time point) of Cmax.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: Tmax of Teropavimab
|
2.24 hours
Interval 0.983 to 2.83
|
1.16 hours
Interval 1.02 to 2.75
|
SECONDARY outcome
Timeframe: Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)Population: Participants in the Zinlirvimab PK Analysis Set with available data were analyzed.
Tmax is defined as the time (observed time point) of Cmax.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=9 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=9 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: Tmax of Zinlirvimab
|
1.00 hours
Interval 0.85 to 1.23
|
1.10 hours
Interval 0.983 to 1.37
|
SECONDARY outcome
Timeframe: Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)Population: Participants in the LEN PK Analysis Set were analyzed.
Tlast is defined as the time (observed time point) of Clast (the last observable concentration of drug).
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: Tlast of LEN
|
364 day
Interval 84.0 to 373.0
|
364 day
Interval 168.0 to 366.0
|
SECONDARY outcome
Timeframe: Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)Population: Participants in the Teropavimab PK Analysis Set were analyzed.
Tlast is defined as the time (observed time point) of Clast (the last observable concentration of drug).
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: Tlast of Teropavimab
|
364 day
Interval 83.9 to 373.0
|
364 day
Interval 168.0 to 366.0
|
SECONDARY outcome
Timeframe: Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)Population: Participants in the Zinlirvimab PK Analysis Set were analyzed.
Tlast is defined as the time (observed time point) of Clast (the last observable concentration of drug).
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=10 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: Tlast of Zinlirvimab
|
364 day
Interval 83.9 to 373.0
|
364 day
Interval 168.0 to 366.0
|
SECONDARY outcome
Timeframe: Week 26Population: Participants in the LEN PK Analysis Set with available data were analyzed.
C26week is the concentration at week 26.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=8 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=8 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: C26week of LEN
|
22.5 ng/mL
Standard Deviation 17.0
|
27.2 ng/mL
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: Week 26Population: Participants in the Teropavimab PK Analysis Set with available data were analyzed.
C26week is the concentration at week 26.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=8 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=8 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: C26week of Teropavimab
|
42.7 μg/mL
Standard Deviation 6.49
|
38.4 μg/mL
Standard Deviation 5.89
|
SECONDARY outcome
Timeframe: Week 26Population: Participants in the Zinlirvimab PK Analysis Set with available data were analyzed.
C26week is the concentration at week 26.
Outcome measures
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=8 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=8 Participants
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|
|
Primary Cohort: PK Parameter: C26week of Zinlirvimab
|
84.6 μg/mL
Standard Deviation 27.1
|
27.2 μg/mL
Standard Deviation 6.44
|
Adverse Events
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Pilot Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Pilot Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=11 participants at risk
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 participants at risk
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Pilot Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=5 participants at risk
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Pilot Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=6 participants at risk
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
20.0%
1/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
Other adverse events
| Measure |
Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=11 participants at risk
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=10 participants at risk
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Pilot Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg
n=5 participants at risk
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
|
Pilot Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg
n=6 participants at risk
Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
|
|---|---|---|---|---|
|
Infections and infestations
Covid-19
|
36.4%
4/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
20.0%
1/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
16.7%
1/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Diabetic foot infection
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Escherichia infection
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
20.0%
2/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
20.0%
1/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
18.2%
2/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abnormal faeces
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
16.7%
1/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
16.7%
1/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Glossitis
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
20.0%
1/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
20.0%
1/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Fatigue
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Injection site bruising
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Injection site discolouration
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Injection site erythema
|
36.4%
4/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
30.0%
3/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
33.3%
2/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Injection site induration
|
18.2%
2/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
40.0%
4/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
50.0%
3/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Injection site inflammation
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Injection site mass
|
27.3%
3/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Injection site nodule
|
36.4%
4/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
20.0%
2/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
20.0%
1/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
16.7%
1/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Injection site oedema
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Injection site pain
|
45.5%
5/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
50.0%
5/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
33.3%
2/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Injection site paraesthesia
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Injection site pruritus
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
33.3%
2/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Injection site reaction
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Bacterial vulvovaginitis
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
18.2%
2/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
20.0%
1/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Hordeolum
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Injection site cellulitis
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Onychomycosis
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
16.7%
1/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Pharyngeal chlamydia infection
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
16.7%
1/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Secondary syphilis
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
20.0%
1/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Shigella infection
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Syphilis
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
27.3%
3/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
16.7%
1/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
16.7%
1/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
16.7%
1/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Investigations
Urine analysis abnormal
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
20.0%
1/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.2%
2/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
20.0%
2/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
16.7%
1/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
16.7%
1/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
16.7%
1/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
16.7%
1/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myokymia
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Tension headache
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
20.0%
2/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Bladder discomfort
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Genital lesion
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
20.0%
2/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
16.7%
1/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
10.0%
1/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.1%
1/11 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/10 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/5 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
0.00%
0/6 • All-Cause Mortality: Up to 55.9 weeks; Adverse Events: Up to 51.1 weeks
All-cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Event: The Safety Analysis Set included all randomized participants who had received at least one dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER