Trial Outcomes & Findings for A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis (NCT NCT06042920)
NCT ID: NCT06042920
Last Updated: 2026-04-17
Results Overview
PASI-75 is defined as the percentage of participants who achieve at least a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) total score. PASI assesses erythema, thickness, and scaling of psoriatic lesions (each rated 0-4), weighted by body region involvement (head, arms, trunk, legs), producing a total score from 0-72, where higher scores indicate more severe disease. Baseline is the Week 0 assessment. PASI-75 responder defined as a 75% improvement from baseline in the PASI score.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
130 participants
Primary outcome timeframe
Week 16
Results posted on
2026-04-17
Participant Flow
Participant milestones
| Measure |
Placebo-Controlled Palmoplantar Psoriasis - BMS-986165 6mg QD
Participants with Palmoplantar Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Palmoplantar Psoriasis - Placebo
Participants with Palmoplantar Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - BMS-986165 6mg QD
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - Placebo
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Active Treatment Palmoplantar Psoriasis - Deucravacitinib 6mg - Deucravacitinib 6mg
Participants with Palmoplantar Psoriasis who earlier received BMS-986165 in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
Active Treatment Palmoplantar Psoriasis - Placebo - Deucravacitinib 6mg
Participants with Palmoplantar Psoriasis who earlier received placebo in placebo contolled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
Active Treatment Genital Psoriasis - Deucravacitinib 6mg - Deucravacitinib 6mg
Participants with Genital Psoriasis who earlier received BMS-986165 in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
Active Treatment Genital Psoriasis - Placebo - Deucravacitinib 6mg
Participants with Genital Psoriasis who earlier received placebo in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
|---|---|---|---|---|---|---|---|---|
|
Placebo-Controlled Period
STARTED
|
30
|
15
|
56
|
29
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
COMPLETED
|
13
|
8
|
29
|
11
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
NOT COMPLETED
|
17
|
7
|
27
|
18
|
0
|
0
|
0
|
0
|
|
Active Treatment Period
STARTED
|
0
|
0
|
0
|
0
|
13
|
8
|
29
|
11
|
|
Active Treatment Period
COMPLETED
|
0
|
0
|
0
|
0
|
3
|
1
|
5
|
2
|
|
Active Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
10
|
7
|
24
|
9
|
Reasons for withdrawal
| Measure |
Placebo-Controlled Palmoplantar Psoriasis - BMS-986165 6mg QD
Participants with Palmoplantar Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Palmoplantar Psoriasis - Placebo
Participants with Palmoplantar Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - BMS-986165 6mg QD
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - Placebo
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Active Treatment Palmoplantar Psoriasis - Deucravacitinib 6mg - Deucravacitinib 6mg
Participants with Palmoplantar Psoriasis who earlier received BMS-986165 in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
Active Treatment Palmoplantar Psoriasis - Placebo - Deucravacitinib 6mg
Participants with Palmoplantar Psoriasis who earlier received placebo in placebo contolled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
Active Treatment Genital Psoriasis - Deucravacitinib 6mg - Deucravacitinib 6mg
Participants with Genital Psoriasis who earlier received BMS-986165 in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
Active Treatment Genital Psoriasis - Placebo - Deucravacitinib 6mg
Participants with Genital Psoriasis who earlier received placebo in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
|---|---|---|---|---|---|---|---|---|
|
Placebo-Controlled Period
Lost to Follow-up
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Site Terminated by Sponsor
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Withdrawal by Subject
|
2
|
2
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Study Terminated by Sponsor
|
15
|
5
|
25
|
13
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Active Treatment Period
Site Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Active Treatment Period
Other reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Active Treatment Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
|
Active Treatment Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Active Treatment Period
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Active Treatment Period
Not Reported
|
0
|
0
|
0
|
0
|
2
|
0
|
2
|
2
|
|
Active Treatment Period
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
6
|
6
|
19
|
5
|
Baseline Characteristics
A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo Contolled - Palmoplantar Psoriasis - BMS-986165 6 mg QD
n=30 Participants
Participants with Palmoplantar Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo Contolled - Palmoplantar Psoriasis - Placebo
n=15 Participants
Participants with Palmoplantar Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo Contolled - Genital Psoriasis - BMS-986165 6mg QD
n=56 Participants
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo Contolled - Genital Psoriasis - Placebo
n=29 Participants
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
WHITE
|
27 Participants
n=130 Participants
|
13 Participants
n=132 Participants
|
49 Participants
n=130 Participants
|
26 Participants
n=392 Participants
|
115 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
UNKNOWN
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
0 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
NOT REPORTED
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
1 Participants
n=65 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
0 Participants
n=65 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=130 Participants
|
10 Participants
n=132 Participants
|
52 Participants
n=130 Participants
|
24 Participants
n=392 Participants
|
107 Participants
n=65 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=130 Participants
|
5 Participants
n=132 Participants
|
4 Participants
n=130 Participants
|
5 Participants
n=392 Participants
|
23 Participants
n=65 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=130 Participants
|
6 Participants
n=132 Participants
|
17 Participants
n=130 Participants
|
9 Participants
n=392 Participants
|
49 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=130 Participants
|
9 Participants
n=132 Participants
|
39 Participants
n=130 Participants
|
20 Participants
n=392 Participants
|
81 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
1 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
3 Participants
n=130 Participants
|
1 Participants
n=132 Participants
|
1 Participants
n=130 Participants
|
1 Participants
n=392 Participants
|
6 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
0 Participants
n=130 Participants
|
1 Participants
n=132 Participants
|
3 Participants
n=130 Participants
|
1 Participants
n=392 Participants
|
5 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
0 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
HISPANIC OR LATINO
|
9 Participants
n=130 Participants
|
3 Participants
n=132 Participants
|
26 Participants
n=130 Participants
|
13 Participants
n=392 Participants
|
51 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
NOT HISPANIC OR LATINO
|
21 Participants
n=130 Participants
|
12 Participants
n=132 Participants
|
29 Participants
n=130 Participants
|
16 Participants
n=392 Participants
|
78 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Full Analysis Set. Pre-defined to be only assessed for Palmoplantar Psoriasis arms. Only number of participants with data available were included in the analysis.
PASI-75 is defined as the percentage of participants who achieve at least a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) total score. PASI assesses erythema, thickness, and scaling of psoriatic lesions (each rated 0-4), weighted by body region involvement (head, arms, trunk, legs), producing a total score from 0-72, where higher scores indicate more severe disease. Baseline is the Week 0 assessment. PASI-75 responder defined as a 75% improvement from baseline in the PASI score.
Outcome measures
| Measure |
Placebo-Controlled Palmoplantar Psoriasis - BMS-986165 6mg QD
n=16 Participants
Participants with Palmoplantar Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo Contolled - Palmoplantar Psoriasis - Placebo
n=9 Participants
Participants with Palmoplantar Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - BMS-986165 6mg QD
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - Placebo
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Palmoplantar Psoriasis Area and Severity Index (Pp-PASI)-75 Response
|
31.3 percentage of participants
Interval 11.0 to 58.7
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 16Population: Full Analysis Set. Pre-defined to be only assessed for Genital Psoriasis arms. Only number of participants with data available were included in the analysis.
The Static Physician's Global Assessment (sPGA) OF Genitalia is a 5-point scale evaluating psoriasis severity based on erythema, scale, and induration. Scores range from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe; higher scores indicate worse disease. The sPGA-G 0/1 response is defined as the percentage of participants achieving a score of 0 or 1 with at least a 2-point improvement from baseline.
Outcome measures
| Measure |
Placebo-Controlled Palmoplantar Psoriasis - BMS-986165 6mg QD
n=31 Participants
Participants with Palmoplantar Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo Contolled - Palmoplantar Psoriasis - Placebo
n=13 Participants
Participants with Palmoplantar Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - BMS-986165 6mg QD
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - Placebo
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Static Physician's Global Assessment of Genitalia (sPGA-G) Response
|
48.4 percentage of participants
Interval 30.2 to 66.9
|
0 percentage of participants
Interval 0.0 to 24.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set. Pre-defined to be only assessed for Palmoplantar Psoriasis arms. Only number of participants with data available were included in the analysis.
The Palmoplantar Physician's Global Assessment (pp-PGA) is a 5-point scale evaluating psoriasis severity based on erythema, scale, and induration. Scores range from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe; higher scores indicate worse disease. The pp-PGA 0/1 response is defined as the percentage of participants achieving a score of 0 or 1 with at least a 2-point improvement from baseline.
Outcome measures
| Measure |
Placebo-Controlled Palmoplantar Psoriasis - BMS-986165 6mg QD
n=16 Participants
Participants with Palmoplantar Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo Contolled - Palmoplantar Psoriasis - Placebo
n=9 Participants
Participants with Palmoplantar Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - BMS-986165 6mg QD
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - Placebo
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieve a Palmoplantar Physician Global Assessment (Pp-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16
|
18.8 percentage of participants
Interval 4.0 to 45.6
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set. Pre-defined to be only assessed for Genital Psoriasis arms. Only number of participants with data available were included in the analysis.
The Genital Psoriasis Symptoms Scale (GPSS) is a participant-administered questionnaire that contains 8 items regarding GenPs symptoms and has a recall period of 24 hours. The items separately address itch, pain, discomfort, stinging, burning, redness, scaling, and cracking on an 11-point scale where 0 represents "no symptom" and 10 represents "worst symptom imaginable". A total score ranging from 0 (no GenPs symptoms) to 80 (worst imaginable GenPs symptoms)
Outcome measures
| Measure |
Placebo-Controlled Palmoplantar Psoriasis - BMS-986165 6mg QD
n=13 Participants
Participants with Palmoplantar Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo Contolled - Palmoplantar Psoriasis - Placebo
n=9 Participants
Participants with Palmoplantar Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - BMS-986165 6mg QD
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - Placebo
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
|---|---|---|---|---|
|
Change From Baseline in Genital Psoriasis Itch (GenPs) Numeric Rating Scale (NRS) Score at Week 16
|
-1.9 score on a scale
Standard Deviation 3.23
|
-0.8 score on a scale
Standard Deviation 2.95
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 through Week 16Population: As-treated population
Adverse Events (AEs) are any new or worsening medical occurrences in participants receiving study treatment, regardless of whether they are related to the treatment. AEs include any unfavorable and unintended sign, symptom, or disease temporally associated with treatment. Serious Adverse Events (SAEs) are defined as events that result in death, are life-threatening, require or prolong hospitalization, cause persistent or significant disability, are congenital anomalies/birth defects, or are otherwise medically significant.
Outcome measures
| Measure |
Placebo-Controlled Palmoplantar Psoriasis - BMS-986165 6mg QD
n=30 Participants
Participants with Palmoplantar Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo Contolled - Palmoplantar Psoriasis - Placebo
n=15 Participants
Participants with Palmoplantar Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - BMS-986165 6mg QD
n=56 Participants
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - Placebo
n=29 Participants
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
Adverse Events
|
17 Participants
|
7 Participants
|
31 Participants
|
15 Participants
|
|
Number of Participants With Adverse Events
Serious Adverse Events
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0 through Week 16Population: As-treated population. Only number of participants with data available were included in the analysis.
Blood samples were collected to assess the laboratory parameters. Laboratory toxicities are graded using NCI CTCAE v3.0. Grade 3 and 4 represent severe and life-threatening abnormalities, respectively.
Outcome measures
| Measure |
Placebo-Controlled Palmoplantar Psoriasis - BMS-986165 6mg QD
n=24 Participants
Participants with Palmoplantar Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo Contolled - Palmoplantar Psoriasis - Placebo
n=9 Participants
Participants with Palmoplantar Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - BMS-986165 6mg QD
n=44 Participants
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - Placebo
n=22 Participants
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
|---|---|---|---|---|
|
Number of Participants With Worst Toxicity Grade 3 or Grade 4 Laboratory Test Results
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0 through Week 16Population: As-treated population. Only number of participants with data available were included in the analysis.
Vital signs assessment included heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP). Heart rate was measured in beats/min and DBP and SBP was measured in mmHG.
Outcome measures
| Measure |
Placebo-Controlled Palmoplantar Psoriasis - BMS-986165 6mg QD
n=30 Participants
Participants with Palmoplantar Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo Contolled - Palmoplantar Psoriasis - Placebo
n=15 Participants
Participants with Palmoplantar Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - BMS-986165 6mg QD
n=56 Participants
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - Placebo
n=29 Participants
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
|---|---|---|---|---|
|
Number of Participants With Vital Sign Summaries Per Categories
HR VALUE > 100 AND CHANGE FROM BASELINE > 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Summaries Per Categories
HR VALUE < 55 AND CHANGE FROM BASELINE < -15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Summaries Per Categories
SBP VALUE > 140 AND CHANGE FROM BASELINE > 20
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Summaries Per Categories
SBP VALUE < 90 AND CHANGE FROM BASELINE < -20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Summaries Per Categories
DBP VALUE > 90 AND CHANGE FROM BASELINE > 10
|
3 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Vital Sign Summaries Per Categories
DBP VALUE < 55 AND CHANGE FROM BASELINE < -10
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Placebo-Controlled Palmoplantar Psoriasis - BMS-986165 6mg QD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo-Controlled Palmoplantar Psoriasis - Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo-Controlled Genital Psoriasis - BMS-986165 6mg QD
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo-Controlled Genital Psoriasis - Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Active Treatment Palmoplantar Psoriasis - Deucravacitinib 6mg - Deucravacitinib 6mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Active Treatment Palmoplantar Psoriasis - Placebo - Deucravacitinib 6mg
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Active Treatment Genital Psoriasis - Deucravacitinib 6mg - Deucravacitinib 6mg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Active Treatment Genital Psoriasis - Placebo - Deucravacitinib 6mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo-Controlled Palmoplantar Psoriasis - BMS-986165 6mg QD
n=30 participants at risk
Participants with Palmoplantar Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Palmoplantar Psoriasis - Placebo
n=15 participants at risk
Participants with Palmoplantar Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - BMS-986165 6mg QD
n=56 participants at risk
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - Placebo
n=29 participants at risk
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Active Treatment Palmoplantar Psoriasis - Deucravacitinib 6mg - Deucravacitinib 6mg
n=13 participants at risk
Participants with Palmoplantar Psoriasis who earlier received BMS-986165 in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
Active Treatment Palmoplantar Psoriasis - Placebo - Deucravacitinib 6mg
n=8 participants at risk
Participants with Palmoplantar Psoriasis who earlier received placebo in placebo contolled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
Active Treatment Genital Psoriasis - Deucravacitinib 6mg - Deucravacitinib 6mg
n=29 participants at risk
Participants with Genital Psoriasis who earlier received BMS-986165 in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
Active Treatment Genital Psoriasis - Placebo - Deucravacitinib 6mg
n=10 participants at risk
Participants with Genital Psoriasis who earlier received placebo in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
12.5%
1/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
7.7%
1/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
12.5%
1/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
1.8%
1/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
3.4%
1/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
3.4%
1/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
3.4%
1/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
3.4%
1/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
Other adverse events
| Measure |
Placebo-Controlled Palmoplantar Psoriasis - BMS-986165 6mg QD
n=30 participants at risk
Participants with Palmoplantar Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Palmoplantar Psoriasis - Placebo
n=15 participants at risk
Participants with Palmoplantar Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - BMS-986165 6mg QD
n=56 participants at risk
Participants with Genital Psoriasis received BMS-986165 6 mg tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Placebo-Controlled Genital Psoriasis - Placebo
n=29 participants at risk
Participants with Genital Psoriasis received placebo tablet once daily from Week 0 to Week 16 in placebo controlled period.
|
Active Treatment Palmoplantar Psoriasis - Deucravacitinib 6mg - Deucravacitinib 6mg
n=13 participants at risk
Participants with Palmoplantar Psoriasis who earlier received BMS-986165 in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
Active Treatment Palmoplantar Psoriasis - Placebo - Deucravacitinib 6mg
n=8 participants at risk
Participants with Palmoplantar Psoriasis who earlier received placebo in placebo contolled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
Active Treatment Genital Psoriasis - Deucravacitinib 6mg - Deucravacitinib 6mg
n=29 participants at risk
Participants with Genital Psoriasis who earlier received BMS-986165 in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
Active Treatment Genital Psoriasis - Placebo - Deucravacitinib 6mg
n=10 participants at risk
Participants with Genital Psoriasis who earlier received placebo in placebo controlled period received 6 mg of BMS-986165 orally once daily in active treatment period till Week 52.
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
6.7%
1/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Investigations
Liver function test increased
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
10.0%
1/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
6.7%
1/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
General disorders
Pyrexia
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
6.9%
2/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
7.7%
1/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
6.7%
1/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Infections and infestations
COVID-19
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
6.9%
2/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
6.7%
1/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
6.7%
1/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Infections and infestations
Influenza
|
6.7%
2/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
6.7%
1/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
3.4%
1/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
7.7%
1/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
3.4%
1/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
2/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
3.6%
2/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
13.8%
4/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
6.9%
2/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Infections and infestations
Pharyngitis
|
6.7%
2/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
3.4%
1/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
1.8%
1/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
7.7%
1/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
10.0%
1/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
7.7%
1/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
12.5%
1/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
3.4%
1/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Infections and infestations
Sinusitis
|
3.3%
1/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
6.7%
1/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
3.6%
2/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
10.0%
1/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
1/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
1.8%
1/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
6.9%
2/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
3.4%
1/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
1.8%
1/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
6.9%
2/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Psychiatric disorders
Depression
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
6.7%
1/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
7.7%
1/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
5.4%
3/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/30 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
6.7%
1/15 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/56 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/13 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/8 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/29 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
0.00%
0/10 • All-cause mortality, serious and non-serious adverse events were collected from Week 0 through Week 52.
All treated population.
|
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 Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER