Trial Outcomes & Findings for A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis (NCT NCT05014438)
NCT ID: NCT05014438
Last Updated: 2023-10-18
Results Overview
The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
From baseline and 16 weeks
Results posted on
2023-10-18
Participant Flow
17 participants randomized and treated
Participant milestones
| Measure |
Placebo
Placebo
|
Treatment 1
BMS-986166 0.25mg POQD
|
Treatment 2
BMS-986166 0.5mg POQD
|
Treatment 3
BMS-986166 0.75mg POQD
|
Treatment 4
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
4
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Total
n=17 Participants
Total of all reporting groups
|
Placebo
n=4 Participants
Placebo
|
Treatment 1
n=3 Participants
BMS-986166 0.25mg POQD
|
Treatment 2
n=4 Participants
BMS-986166 0.5mg POQD
|
Treatment 3
n=3 Participants
BMS-986166 0.75mg POQD
|
Treatment 4
n=3 Participants
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.2 Years
STANDARD_DEVIATION 12.5 • n=10 Participants
|
30.5 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
36.0 Years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
29.5 Years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
46.7 Years
STANDARD_DEVIATION 8.3 • n=4 Participants
|
36.7 Years
STANDARD_DEVIATION 17.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=10 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=10 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From baseline and 16 weeksPopulation: mITT population with evaluable EASI score at baseline and week 16. mITT: Modified Intent-To-Treat (All participants who are randomized and received at least one dose of study treatment)
The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better.
Outcome measures
| Measure |
Placebo
n=1 Participants
Placebo
|
Treatment 1
BMS-986166 0.25mg POQD
|
Treatment 2
BMS-986166 0.5mg POQD
|
Treatment 3
BMS-986166 0.75mg POQD
|
Treatment 4
n=1 Participants
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in EASI Score at Week 16
|
-83.1 Percentage change
Standard Deviation NA
Insufficient number of participants analyzed to calculate SD
|
—
|
—
|
—
|
-92.3 Percentage change
Standard Deviation NA
Insufficient number of participants analyzed to calculate SD
|
SECONDARY outcome
Timeframe: From baseline and 16 weeksPopulation: mITT population with evaluable vIGA-AD at baseline. mITT: Modified Intent-To-Treat (All participants who are randomized and received at least one dose of study treatment)
The vIGA-AD is a static 5-point assessment intended to assess the global severities of key acute clinical signs of AD, including erythema, induration/papulation, and oozing/crusting (lichenification excluded). The rating of cleared (0), almost cleared (1), mild (2), moderate (3), and severe (4) will be assessed.
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo
|
Treatment 1
n=3 Participants
BMS-986166 0.25mg POQD
|
Treatment 2
n=4 Participants
BMS-986166 0.5mg POQD
|
Treatment 3
n=3 Participants
BMS-986166 0.75mg POQD
|
Treatment 4
n=3 Participants
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Percentage of Participants Exhibiting a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 (Cleared) or 1 (Almost Cleared) AND a ≥ 2 Point Reduction From Baseline at Week 16
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 70.8
|
SECONDARY outcome
Timeframe: From baseline and 16 weeksPopulation: mITTpopulationIntent-To-Treat (All participants who are randomized and received at least one dose of study treatment)
The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better.
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo
|
Treatment 1
n=3 Participants
BMS-986166 0.25mg POQD
|
Treatment 2
n=4 Participants
BMS-986166 0.5mg POQD
|
Treatment 3
n=3 Participants
BMS-986166 0.75mg POQD
|
Treatment 4
n=3 Participants
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Percentage of Participants Exhibiting a ≥ 50% (EASI-50) Reduction From Baseline in EASI Score at Week 16
|
25 Percentage of participants
Interval 0.6 to 80.6
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 70.8
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
SECONDARY outcome
Timeframe: From baseline and 16 weeksPopulation: mITT population with evaluable baseline pruritis NRS greater than or equal to 4. mITT: Modified Intent-To-Treat (All participants who are randomized and received at least one dose of study treatment)
Participants will complete a daily diary recording the intensity of their pruritus they experienced during the preceding 24 hours. The intensity of pruritus will be assessed using a validated 11-point NRS, ranging from 0 ("no itching") to 10 ("the worst itching imaginable"). The lower the score the better.
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo
|
Treatment 1
n=3 Participants
BMS-986166 0.25mg POQD
|
Treatment 2
n=2 Participants
BMS-986166 0.5mg POQD
|
Treatment 3
n=2 Participants
BMS-986166 0.75mg POQD
|
Treatment 4
n=2 Participants
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Percentage of Participants Exhibiting a ≥ 4-point Improvement From Baseline in Pruritus NRS at Week 16
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 84.2
|
50 Percentage of participants
Interval 1.3 to 98.7
|
50 Percentage of participants
Interval 1.3 to 98.7
|
SECONDARY outcome
Timeframe: From baseline and 16 weeksPopulation: mITT population with evaluable Pruritus NRS at baseline and week 16. mITT: Modified Intent-To-Treat (All participants who are randomized and received at least one dose of study treatment)
Participants will complete a daily diary recording the intensity of their pruritus and the average quality of sleep they experienced during the preceding 24 hours. The intensity of pruritus will be assessed using a validated 11-point NRS, ranging from 0 ("no itching") to 10 ("the worst itching imaginable"). The quality of sleep will be assessed using a validated 11-point NRS ranging from 0 ("the best possible sleep") to 10 ("the worst possible sleep). The lower the score the better.
Outcome measures
| Measure |
Placebo
n=1 Participants
Placebo
|
Treatment 1
BMS-986166 0.25mg POQD
|
Treatment 2
BMS-986166 0.5mg POQD
|
Treatment 3
n=1 Participants
BMS-986166 0.75mg POQD
|
Treatment 4
n=1 Participants
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in Pruritus NRS Score at Week 16
|
-89.6 Percentage change
Standard Deviation NA
Too few participants to calculate SD
|
—
|
—
|
-100 Percentage change
Standard Deviation NA
Too few participants to calculate SD
|
-86.8 Percentage change
Standard Deviation NA
Too few participants to calculate SD
|
SECONDARY outcome
Timeframe: From baseline and 16 weeksPopulation: mITT population with evaluable baseline and week 16 BSA measurement. mITT: Modified Intent-To-Treat (All participants who are randomized and received at least one dose of study treatment)
A widely used method of measuring Body Surface Area (BSA) involvement by AD, is the rule of nines in which for each section of the body (the possible highest score for each region is: head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], genitals \[1%\]) and will be reported as a percentage of all major body sections combined.
Outcome measures
| Measure |
Placebo
n=1 Participants
Placebo
|
Treatment 1
BMS-986166 0.25mg POQD
|
Treatment 2
BMS-986166 0.5mg POQD
|
Treatment 3
BMS-986166 0.75mg POQD
|
Treatment 4
n=1 Participants
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Percentage of Affected BSA at Week 16
|
-17.00 Percentage change
Standard Deviation NA
Too few participants to calculate SD
|
—
|
—
|
—
|
-12.10 Percentage change
Standard Deviation NA
Too few participants to calculate SD
|
SECONDARY outcome
Timeframe: From initial treatment to 30 days post discontinuation, approximately 29 weeksPopulation: Safety Population
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. Mild: An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that causes sufficient discomfort and interferes with normal everyday activities. Severe: An event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilized for rating the intensity of an event, and both AEs and SAEs can be assessed as severe.
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo
|
Treatment 1
n=3 Participants
BMS-986166 0.25mg POQD
|
Treatment 2
n=4 Participants
BMS-986166 0.5mg POQD
|
Treatment 3
n=3 Participants
BMS-986166 0.75mg POQD
|
Treatment 4
n=3 Participants
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Number of Participants With Mild Moderate or Severe AEs
Mild
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Mild Moderate or Severe AEs
Moderate
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Mild Moderate or Severe AEs
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From initial treatment to 30 days post discontinuation, approximately 29 weeksPopulation: Safety Population
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death * is life threatening * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability * Is a congenital anomaly/birth defect. * Is an important medical event
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo
|
Treatment 1
n=3 Participants
BMS-986166 0.25mg POQD
|
Treatment 2
n=4 Participants
BMS-986166 0.5mg POQD
|
Treatment 3
n=3 Participants
BMS-986166 0.75mg POQD
|
Treatment 4
n=3 Participants
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Number of Participants With Mild Moderate or Severe SAEs
Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Mild Moderate or Severe SAEs
Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Mild Moderate or Severe SAEs
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 24 after initial treatmentPopulation: Safety Population
12 Lead Electrocardiogram (ECG). The participant will remain supine for 5 to 10 minutes prior to the ECG and must have lab work done after the tracing so that the ECG results remain as accurate as possible.
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo
|
Treatment 1
n=3 Participants
BMS-986166 0.25mg POQD
|
Treatment 2
n=4 Participants
BMS-986166 0.5mg POQD
|
Treatment 3
n=3 Participants
BMS-986166 0.75mg POQD
|
Treatment 4
n=3 Participants
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Relevant ECG Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 24 after initial treatmentPopulation: Safety population
Optical coherence tomography (OCT) is a non-invasive imaging test. It uses light waves to take cross-section pictures of your retina. Diagnosis is made by an ophthalmologist.
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo
|
Treatment 1
n=3 Participants
BMS-986166 0.25mg POQD
|
Treatment 2
n=4 Participants
BMS-986166 0.5mg POQD
|
Treatment 3
n=3 Participants
BMS-986166 0.75mg POQD
|
Treatment 4
n=3 Participants
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Relevant OCT Abnormalities
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 24 after initial treatmentPopulation: Safety Population
Pulmonary function tests (PFT) include: forced expiratory volume (FEV1), percent predicted FEV1, forced vital capacity (FVC), percent predicted FVC, and Diffusion capacity of carbon monoxide (DLCO).
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo
|
Treatment 1
n=3 Participants
BMS-986166 0.25mg POQD
|
Treatment 2
n=4 Participants
BMS-986166 0.5mg POQD
|
Treatment 3
n=3 Participants
BMS-986166 0.75mg POQD
|
Treatment 4
n=3 Participants
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Relevant PFT Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 24 after initial treatmentPopulation: Safety Population
The following vital signs will be assessed: systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and body temperature.
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo
|
Treatment 1
n=3 Participants
BMS-986166 0.25mg POQD
|
Treatment 2
n=4 Participants
BMS-986166 0.5mg POQD
|
Treatment 3
n=3 Participants
BMS-986166 0.75mg POQD
|
Treatment 4
n=3 Participants
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Meaningful Changes in Vital Signs
Respiratory Rate
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Clinically Meaningful Changes in Vital Signs
Heart Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Meaningful Changes in Vital Signs
Diastolic Blood Pressure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Meaningful Changes in Vital Signs
Systolic Blood Pressure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Meaningful Changes in Vital Signs
Body Temperature
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 24 after initial treatmentPopulation: Safety Population
Liver Function Tests (LFTs) will include the following measurements: * ALT OR AST \> 3 X ULN * ALT OR AST \> 5 X ULN * ALT OR AST \> 8 X ULN * TOTAL BILIRUBIN \> 2 X ULN * ALT OR AST \> 3 X ULN AND (TOTAL BILIRUBIN \> 2 X ULN OR INR \>1.5) AST = aspartate aminotransferase ALT = alanine aminotransferase ULN = Upper limit number INR = International Normalized Ratio
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo
|
Treatment 1
n=3 Participants
BMS-986166 0.25mg POQD
|
Treatment 2
n=4 Participants
BMS-986166 0.5mg POQD
|
Treatment 3
n=3 Participants
BMS-986166 0.75mg POQD
|
Treatment 4
n=3 Participants
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Changes in LFTs
ALT OR AST > 3 X ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Relevant Changes in LFTs
ALT OR AST > 5 X ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Relevant Changes in LFTs
ALT OR AST > 8 X ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Relevant Changes in LFTs
TOTAL BILIRUBIN > 2 X ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Relevant Changes in LFTs
ALT OR AST > 3 X ULN AND (TOTAL BILIRUBIN > 2 X ULN OR INR >1.5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Relevant Changes in LFTs
ALT OR AST > 5 X ULN WITH CONFIRMATION, WITHIN 2 WEEKS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=4 participants at risk
Placebo
|
Treatment 1
n=3 participants at risk
BMS-986166 0.25mg POQD
|
Treatment 2
n=4 participants at risk
BMS-986166 0.5mg POQD
|
Treatment 3
n=3 participants at risk
BMS-986166 0.75mg POQD
|
Treatment 4
n=3 participants at risk
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Infections and infestations
Eczema herpeticum
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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 |
Placebo
n=4 participants at risk
Placebo
|
Treatment 1
n=3 participants at risk
BMS-986166 0.25mg POQD
|
Treatment 2
n=4 participants at risk
BMS-986166 0.5mg POQD
|
Treatment 3
n=3 participants at risk
BMS-986166 0.75mg POQD
|
Treatment 4
n=3 participants at risk
Branebrutinib 9mg POQD
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
|
Eye disorders
Macular degeneration
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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 upper
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
Nodule
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
Furuncle
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
Skin bacterial infection
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
Diabetes mellitus inadequate control
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
Hyperuricaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
Depressed mood
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
Dermatitis atopic
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
Skin mass
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 29 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
The number at Risk for All-Cause Mortality represents all Randomized 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