Trial Outcomes & Findings for Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis (NCT NCT03934216)
NCT ID: NCT03934216
Last Updated: 2024-03-06
Results Overview
Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding. Will be calculated using a modified Mayo score with the following: Stool Frequency (SF) sub score ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) sub score = 0, and Endoscopic (ES) sub score ≤ 1 (modified, excludes friability) The modified Mayo score (0 to 9 points) is the sum of 3 components: the SF, RB, and ES sub scores Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points (inclusive), which is required for randomization, denotes moderate to severe disease (by protocol definition). considered in clinical remission if a Mayo Score of less than or equal to 2 with no individual sub score greater than 1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
From first dose to 12 weeks.
Results posted on
2024-03-06
Participant Flow
131 Participants Randomized and 129 Treated
Participant milestones
| Measure |
Treatment
BMS-986-165 6mg BID
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
43
|
|
Overall Study
COMPLETED
|
30
|
12
|
|
Overall Study
NOT COMPLETED
|
58
|
31
|
Reasons for withdrawal
| Measure |
Treatment
BMS-986-165 6mg BID
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
Other Reasons
|
5
|
5
|
|
Overall Study
Adverse Event
|
22
|
11
|
|
Overall Study
Lack of Efficacy
|
8
|
7
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Non-Compliance with Study Drug
|
1
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
18
|
6
|
|
Overall Study
Randomized but not treated
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Treatment
n=88 Participants
BMS-986-165 6mg BID
|
Placebo
n=43 Participants
Placebo
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.6 Years
STANDARD_DEVIATION 14.81 • n=5 Participants
|
40.3 Years
STANDARD_DEVIATION 13.91 • n=7 Participants
|
41.2 Years
STANDARD_DEVIATION 14.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose to 12 weeks.Population: All Randomized Participants
Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding. Will be calculated using a modified Mayo score with the following: Stool Frequency (SF) sub score ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) sub score = 0, and Endoscopic (ES) sub score ≤ 1 (modified, excludes friability) The modified Mayo score (0 to 9 points) is the sum of 3 components: the SF, RB, and ES sub scores Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points (inclusive), which is required for randomization, denotes moderate to severe disease (by protocol definition). considered in clinical remission if a Mayo Score of less than or equal to 2 with no individual sub score greater than 1
Outcome measures
| Measure |
Treatment
n=88 Participants
BMS-986-165 6mg BID
|
Placebo
n=43 Participants
Placebo
|
|---|---|---|
|
Clinical Remission Response Rate at Week 12
|
14.8 Percentage of Participants
Interval 7.4 to 22.2
|
16.3 Percentage of Participants
Interval 5.2 to 27.3
|
SECONDARY outcome
Timeframe: From first dose to 12 weeksPopulation: All Randomized Participants
Clinical response is defined as percentage of participants with a reduction in total Mayo Score and reduction in rectal bleeding subscore Will be defined as the following: A decrease from baseline in the modified Mayo score of ≥ 2 points, and A decrease from baseline in the modified Mayo score ≥ 30%, and A decrease in rectal bleeding(RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1
Outcome measures
| Measure |
Treatment
n=88 Participants
BMS-986-165 6mg BID
|
Placebo
n=43 Participants
Placebo
|
|---|---|---|
|
Clinical Response Rate at 12 Weeks
|
37.5 Percentage of participants
Interval 27.4 to 47.6
|
32.6 Percentage of participants
Interval 18.6 to 46.6
|
SECONDARY outcome
Timeframe: up to 12 WeeksPopulation: All Randomized Participants
Endoscopic response will be defined as percentage of participants with a reduction in the total Ulcerative Colitis Endoscopic Index of Severity score. The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scale: Vascular Pattern: * Normal (score 0) * patchy obliteration (score 1) * Obliterated (score 2) Bleeding * None (score 0) * Mucosal (score 1) * Luminal mild (score 2) * Luminal Moderate or severe (score 3) Erosions and Ulcers * None (score 0) * Erosions ( score 1) * Superficial Ulcer (2) * Deep Ulcer (score 3) A total score represents the following: remission (0-1); mild (2-4); moderate (5-6); and severe (7-8).
Outcome measures
| Measure |
Treatment
n=88 Participants
BMS-986-165 6mg BID
|
Placebo
n=43 Participants
Placebo
|
|---|---|---|
|
Endoscopic Response at Week 12
|
19.3 Percentage of Participants
Interval 11.1 to 27.6
|
27.9 Percentage of Participants
Interval 14.5 to 41.3
|
SECONDARY outcome
Timeframe: up to 12 WeeksPopulation: All Randomized Participants
Histologic improvement is defined as percentage of participants with a Geboes score of ≤ 3.1 Neutrophils \<5% of crypts, with no crypt destruction, erosions, ulcerations, and granulation tissue. Achieving the following scores for the corresponding grades of the Geboes score: * Score of 0 or 1 for Grade 3 (neutrophils in the epithelium: none or \< 5% crypts involved), and * Score of 0 for Grade 4 (crypt destruction: none), and * Score of 0 Grade 5 (erosion or ulceration: no erosions, ulcerations, or granulation tissue) grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease
Outcome measures
| Measure |
Treatment
n=88 Participants
BMS-986-165 6mg BID
|
Placebo
n=43 Participants
Placebo
|
|---|---|---|
|
Histological Improvement Response Rate at 12 Weeks
|
21.6 Percentage of Participants
Interval 13.0 to 30.2
|
16.3 Percentage of Participants
Interval 5.2 to 27.3
|
Adverse Events
Treatment
Serious events: 19 serious events
Other events: 64 other events
Deaths: 2 deaths
Placebo
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
BMS-986165 6mg BID During OL Period After Receiving Placebo in Induction Period
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=87 participants at risk
BMS-986-165 6mg BID
|
Placebo
n=10 participants at risk
Placebo
|
BMS-986165 6mg BID During OL Period After Receiving Placebo in Induction Period
n=32 participants at risk
BMS-986165 6mg BID during OL period after receiving Placebo in Induction period
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Congenital, familial and genetic disorders
Congenital aural fistula
|
0.00%
0/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
1/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis ulcerative
|
3.4%
3/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Anal abscess
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19 pneumonia
|
9.2%
8/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
1/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Suicide attempt
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Treatment
n=87 participants at risk
BMS-986-165 6mg BID
|
Placebo
n=10 participants at risk
Placebo
|
BMS-986165 6mg BID During OL Period After Receiving Placebo in Induction Period
n=32 participants at risk
BMS-986165 6mg BID during OL period after receiving Placebo in Induction period
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.6%
4/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
7/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
1/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Aphthous ulcer
|
5.7%
5/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis ulcerative
|
19.5%
17/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
8/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
5/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
1/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Feeling cold
|
0.00%
0/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
3.4%
3/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.6%
5/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
14.9%
13/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
18.8%
6/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Influenza
|
3.4%
3/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
6/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
4/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Oral herpes
|
2.3%
2/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
1/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sinusitis
|
5.7%
5/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
1/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Tonsillitis
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
5/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
1/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
1/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood alkaline phosphatase increased
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Hepatitis B DNA assay positive
|
0.00%
0/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
5/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
4/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
1/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.4%
3/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Acne
|
10.3%
9/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.9%
13/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.4%
3/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
1.1%
1/87 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
2/32 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60