Trial Outcomes & Findings for A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 (NCT NCT03969888)
NCT ID: NCT03969888
Last Updated: 2023-06-28
Results Overview
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. Mixed-effect model with repeated measures (MMRM) was used for the analyses.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
Day 1 (Baseline) through Day 29
Results posted on
2023-06-28
Participant Flow
Participants with Cystic Fibrosis (CF) who are homozygous for the F508del mutation were enrolled in this 2-part study to receive ABBV-3067 alone and in combination with ABBV-2222 for 28 days. In Part 1 participants received 2 different doses of ABBV-3067 as a single agent, and 5 different doses of ABBV-2222 as dual-combination therapy with ABBV-3067 at a fixed dose. Part 2 of the study was not conducted as it was deemed not enrollable by the time Part 1 was completed.
Participant milestones
| Measure |
ABBV-3067 50 mg + Placebo for ABBV-2222
Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + Placebo for ABBV-2222
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 10 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 30 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 100 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 200 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 300 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
|
Placebo for ABBV-3067 + Placebo for ABBV-2222
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
5
|
12
|
11
|
12
|
14
|
11
|
|
Overall Study
COMPLETED
|
6
|
7
|
4
|
12
|
11
|
12
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
ABBV-3067 50 mg + Placebo for ABBV-2222
Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + Placebo for ABBV-2222
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 10 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 30 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 100 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 200 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 300 mg
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
|
Placebo for ABBV-3067 + Placebo for ABBV-2222
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Never Received Study Drug
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Reason Not Specified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Number analyzed are the number of participants with data available for analysis for ppFEV1 at baseline
Baseline characteristics by cohort
| Measure |
ABBV-3067 50 mg + Placebo for ABBV-2222
n=6 Participants
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + Placebo for ABBV-2222
n=7 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 10 mg
n=5 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 30 mg
n=12 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 100 mg
n=11 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 200 mg
n=12 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 300 mg
n=14 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
|
Placebo for ABBV-3067 + Placebo for ABBV-2222
n=11 Participants
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.5 years
STANDARD_DEVIATION 4.46 • n=6 Participants
|
31.6 years
STANDARD_DEVIATION 7.39 • n=7 Participants
|
36.4 years
STANDARD_DEVIATION 15.50 • n=5 Participants
|
33.8 years
STANDARD_DEVIATION 12.67 • n=12 Participants
|
32.5 years
STANDARD_DEVIATION 12.53 • n=11 Participants
|
32.5 years
STANDARD_DEVIATION 13.13 • n=12 Participants
|
31.9 years
STANDARD_DEVIATION 9.00 • n=14 Participants
|
26.8 years
STANDARD_DEVIATION 6.68 • n=11 Participants
|
31.5 years
STANDARD_DEVIATION 10.64 • n=78 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=12 Participants
|
5 Participants
n=11 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=14 Participants
|
4 Participants
n=11 Participants
|
30 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=12 Participants
|
6 Participants
n=11 Participants
|
10 Participants
n=12 Participants
|
11 Participants
n=14 Participants
|
7 Participants
n=11 Participants
|
48 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
12 Participants
n=12 Participants
|
14 Participants
n=14 Participants
|
11 Participants
n=11 Participants
|
78 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
12 Participants
n=12 Participants
|
14 Participants
n=14 Participants
|
11 Participants
n=11 Participants
|
78 Participants
n=78 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=78 Participants
|
|
Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1 ) at Baseline
|
67.0 percent predicted FEV1 (%)
STANDARD_DEVIATION 15.89 • n=6 Participants • Number analyzed are the number of participants with data available for analysis for ppFEV1 at baseline
|
68.6 percent predicted FEV1 (%)
STANDARD_DEVIATION 11.16 • n=7 Participants • Number analyzed are the number of participants with data available for analysis for ppFEV1 at baseline
|
65.8 percent predicted FEV1 (%)
STANDARD_DEVIATION 18.96 • n=4 Participants • Number analyzed are the number of participants with data available for analysis for ppFEV1 at baseline
|
64.6 percent predicted FEV1 (%)
STANDARD_DEVIATION 16.84 • n=12 Participants • Number analyzed are the number of participants with data available for analysis for ppFEV1 at baseline
|
68.1 percent predicted FEV1 (%)
STANDARD_DEVIATION 14.48 • n=11 Participants • Number analyzed are the number of participants with data available for analysis for ppFEV1 at baseline
|
62.0 percent predicted FEV1 (%)
STANDARD_DEVIATION 15.18 • n=12 Participants • Number analyzed are the number of participants with data available for analysis for ppFEV1 at baseline
|
67.6 percent predicted FEV1 (%)
STANDARD_DEVIATION 17.83 • n=13 Participants • Number analyzed are the number of participants with data available for analysis for ppFEV1 at baseline
|
67.8 percent predicted FEV1 (%)
STANDARD_DEVIATION 13.19 • n=11 Participants • Number analyzed are the number of participants with data available for analysis for ppFEV1 at baseline
|
66.3 percent predicted FEV1 (%)
STANDARD_DEVIATION 14.96 • n=76 Participants • Number analyzed are the number of participants with data available for analysis for ppFEV1 at baseline
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: FAS included all randomized participants who received at least 1 dose of study drug. Overall number of participants are the number of participants with data available for analyses.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. Mixed-effect model with repeated measures (MMRM) was used for the analyses.
Outcome measures
| Measure |
ABBV-3067 50 mg + Placebo for ABBV-2222
n=5 Participants
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + Placebo for ABBV-2222
n=5 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 10 mg
n=2 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 30 mg
n=5 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 100 mg
n=10 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 200 mg
n=11 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 300 mg
n=11 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
|
Placebo for ABBV-3067 + Placebo for ABBV-2222
n=9 Participants
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
0.3 percent predicted FEV1 (%)
Interval -4.38 to 4.98
|
-2.2 percent predicted FEV1 (%)
Interval -7.03 to 2.66
|
2.0 percent predicted FEV1 (%)
Interval -5.07 to 9.07
|
4.5 percent predicted FEV1 (%)
Interval -0.16 to 9.08
|
0.3 percent predicted FEV1 (%)
Interval -3.13 to 3.68
|
4.0 percent predicted FEV1 (%)
Interval 0.79 to 7.28
|
2.4 percent predicted FEV1 (%)
Interval -0.85 to 5.74
|
-2.2 percent predicted FEV1 (%)
Interval -5.83 to 1.43
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: FAS included all randomized participants who received at least 1 dose of study drug. Overall number of participants are the number of participants with data available for analyses.
Sweat collection was performed to evaluate sweat chloride concentration. SwCl is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) activity. Persons with CF have higher levels of chloride in their sweat. MMRM was used for the analysis.
Outcome measures
| Measure |
ABBV-3067 50 mg + Placebo for ABBV-2222
n=5 Participants
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + Placebo for ABBV-2222
n=7 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 10 mg
n=3 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 30 mg
n=11 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 100 mg
n=10 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 200 mg
n=12 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 300 mg
n=13 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
|
Placebo for ABBV-3067 + Placebo for ABBV-2222
n=9 Participants
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)
|
-4.5 millimole per liter (mmol/L)
Interval -15.78 to 6.81
|
-8.9 millimole per liter (mmol/L)
Interval -18.64 to 0.78
|
-2.3 millimole per liter (mmol/L)
Interval -16.76 to 12.25
|
-15.7 millimole per liter (mmol/L)
Interval -23.37 to -7.98
|
-12.3 millimole per liter (mmol/L)
Interval -20.34 to -4.26
|
-18.6 millimole per liter (mmol/L)
Interval -25.98 to -11.16
|
-19.9 millimole per liter (mmol/L)
Interval -27.17 to -12.64
|
-2.1 millimole per liter (mmol/L)
Interval -10.63 to 6.36
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: FAS included all randomized participants who received at least 1 dose of study drug. Overall number of participants are the number of participants with data available for analyses.
FVC is the total amount of air exhaled during forced expiratory volume (FEV) test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
Outcome measures
| Measure |
ABBV-3067 50 mg + Placebo for ABBV-2222
n=5 Participants
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + Placebo for ABBV-2222
n=5 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 10 mg
n=2 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 30 mg
n=5 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 100 mg
n=10 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 200 mg
n=11 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 300 mg
n=11 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
|
Placebo for ABBV-3067 + Placebo for ABBV-2222
n=9 Participants
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
|
0.0 liter (L)
Interval -0.22 to 0.23
|
-0.0 liter (L)
Interval -0.24 to 0.2
|
0.0 liter (L)
Interval -0.28 to 0.35
|
0.1 liter (L)
Interval -0.16 to 0.28
|
0.1 liter (L)
Interval -0.08 to 0.24
|
0.0 liter (L)
Interval -0.11 to 0.19
|
0.0 liter (L)
Interval -0.12 to 0.19
|
-0.2 liter (L)
Interval -0.38 to -0.03
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: FAS included all randomized participants who received at least 1 dose of study drug. Overall number of participants are the number of participants with data available for analyses.
FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
Outcome measures
| Measure |
ABBV-3067 50 mg + Placebo for ABBV-2222
n=5 Participants
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + Placebo for ABBV-2222
n=5 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 10 mg
n=2 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 30 mg
n=5 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 100 mg
n=10 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 200 mg
n=11 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 300 mg
n=11 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
|
Placebo for ABBV-3067 + Placebo for ABBV-2222
n=9 Participants
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
|
0.0 liter per seconds (L/sec)
Interval -0.27 to 0.29
|
-0.0 liter per seconds (L/sec)
Interval -0.29 to 0.27
|
0.2 liter per seconds (L/sec)
Interval -0.26 to 0.57
|
0.2 liter per seconds (L/sec)
Interval -0.08 to 0.47
|
-0.0 liter per seconds (L/sec)
Interval -0.23 to 0.18
|
0.3 liter per seconds (L/sec)
Interval 0.08 to 0.47
|
0.1 liter per seconds (L/sec)
Interval -0.08 to 0.31
|
0.0 liter per seconds (L/sec)
Interval -0.2 to 0.24
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: FAS included all randomized participants who received at least 1 dose of study drug. Overall number of participants are the number of participants with data available for analyses.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. MMRM was used for analyses.
Outcome measures
| Measure |
ABBV-3067 50 mg + Placebo for ABBV-2222
n=5 Participants
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + Placebo for ABBV-2222
n=5 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 10 mg
n=2 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 30 mg
n=5 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 100 mg
n=10 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 200 mg
n=11 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 300 mg
n=11 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
|
Placebo for ABBV-3067 + Placebo for ABBV-2222
n=9 Participants
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
1.0 percent predicted FEV1
Interval -6.22 to 8.22
|
-2.9 percent predicted FEV1
Interval -10.38 to 4.6
|
3.4 percent predicted FEV1
Interval -7.46 to 14.34
|
8.0 percent predicted FEV1
Interval 0.87 to 15.14
|
1.4 percent predicted FEV1
Interval -3.82 to 6.69
|
5.7 percent predicted FEV1
Interval 0.7 to 10.73
|
4.7 percent predicted FEV1
Interval -0.35 to 9.84
|
-3.3 percent predicted FEV1
Interval -8.86 to 2.34
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: FAS included all randomized participants who received at least 1 dose of study drug. Overall number of participants are the number of participants with data available for analyses.
FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
Outcome measures
| Measure |
ABBV-3067 50 mg + Placebo for ABBV-2222
n=5 Participants
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + Placebo for ABBV-2222
n=5 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 10 mg
n=2 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 30 mg
n=5 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 100 mg
n=10 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 200 mg
n=11 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 300 mg
n=11 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
|
Placebo for ABBV-3067 + Placebo for ABBV-2222
n=9 Participants
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
|
0.8 L/sec
Interval -18.01 to 19.55
|
-0.1 L/sec
Interval -18.94 to 18.76
|
8.8 L/sec
Interval -18.69 to 36.38
|
19.9 L/sec
Interval 1.61 to 38.28
|
0.1 L/sec
Interval -13.46 to 13.65
|
18.5 L/sec
Interval 5.6 to 31.5
|
10.9 L/sec
Interval -2.21 to 24.01
|
1.0 L/sec
Interval -13.69 to 15.62
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: FAS included all randomized participants who received at least 1 dose of study drug. Overall number of participants are the number of participants with data available for analyses.
FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
Outcome measures
| Measure |
ABBV-3067 50 mg + Placebo for ABBV-2222
n=5 Participants
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + Placebo for ABBV-2222
n=5 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 10 mg
n=2 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 30 mg
n=5 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 100 mg
n=10 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 200 mg
n=11 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 300 mg
n=11 Participants
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
|
Placebo for ABBV-3067 + Placebo for ABBV-2222
n=9 Participants
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
|
0.1 liter
Interval -5.2 to 5.35
|
-1.0 liter
Interval -6.38 to 4.3
|
0.2 liter
Interval -7.37 to 7.82
|
2.2 liter
Interval -3.03 to 7.43
|
2.2 liter
Interval -1.51 to 6.01
|
0.9 liter
Interval -2.77 to 4.54
|
1.1 liter
Interval -2.58 to 4.73
|
-4.3 liter
Interval -8.37 to -0.2
|
Adverse Events
ABBV-3067 50 mg + Placebo for ABBV-2222
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ABBV-3067 150 mg + Placebo for ABBV-2222
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
ABBV-3067 150 mg + ABBV-2222 10 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ABBV-3067 150 mg + ABBV-2222 30 mg
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
ABBV-3067 150 mg + ABBV-2222 100 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
ABBV-3067 150 mg + ABBV-2222 200 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
ABBV-3067 150 mg + ABBV-2222 300 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo for ABBV-3067 + Placebo for ABBV-2222
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABBV-3067 50 mg + Placebo for ABBV-2222
n=6 participants at risk
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + Placebo for ABBV-2222
n=7 participants at risk
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 10 mg
n=4 participants at risk
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 30 mg
n=12 participants at risk
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 100 mg
n=11 participants at risk
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 200 mg
n=12 participants at risk
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 300 mg
n=13 participants at risk
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
|
Placebo for ABBV-3067 + Placebo for ABBV-2222
n=11 participants at risk
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
ABBV-3067 50 mg + Placebo for ABBV-2222
n=6 participants at risk
Participants received ABBV-3067 50 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + Placebo for ABBV-2222
n=7 participants at risk
Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 10 mg
n=4 participants at risk
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 30 mg
n=12 participants at risk
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 100 mg
n=11 participants at risk
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 200 mg
n=12 participants at risk
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.
|
ABBV-3067 150 mg + ABBV-2222 300 mg
n=13 participants at risk
Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.
|
Placebo for ABBV-3067 + Placebo for ABBV-2222
n=11 participants at risk
Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Congenital, familial and genetic disorders
CYSTIC FIBROSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
MYOPIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
50.0%
2/4 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
18.2%
2/11 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
FREQUENT BOWEL MOVEMENTS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
RETCHING
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
CHEST PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
FATIGUE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
PYREXIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
BACTERIURIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
27.3%
3/11 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
18.2%
2/11 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
NASOPHARYNGITIS
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
RASH PUSTULAR
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
SIALOADENITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
SINUSITIS
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
BLOOD GLUCOSE DECREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
FORCED EXPIRATORY VOLUME DECREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
INCREASED APPETITE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
18.2%
2/11 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
18.2%
2/11 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
PANIC ATTACK
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
18.2%
2/11 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
18.2%
2/11 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DRY THROAT
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
18.2%
2/11 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL ERYTHEMA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RALES
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
18.2%
2/11 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
SPUTUM INCREASED
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
PAPULE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
FLUSHING
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; maximum median time was 28.0 days. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from first dose of study drug until 30 days after last dose of study drug (Up to 63 days); mean duration on study drug was 28.3 days.
All-cause mortality: all enrolled participants. SAEs and other adverse events: FAS includes all randomized participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER