Trial Outcomes & Findings for BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT02684370)
NCT ID: NCT02684370
Last Updated: 2021-07-30
Results Overview
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
560 participants
Primary outcome timeframe
Week 16
Results posted on
2021-07-30
Participant Flow
A total of 560 subjects were enrolled; 54 subjects failed screening and are excluded from the analyses.
Participant milestones
| Measure |
Placebo (Part A)
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Ustekinumab (Part A)
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Placebo/Risankizumab (Part B)
Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Ustekinumab/Ustekinumab (Part B)
Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Risankizumab/Risankizumab (Part B)
Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|---|---|
|
Part A
STARTED
|
102
|
100
|
304
|
0
|
0
|
0
|
|
Part A
COMPLETED
|
98
|
99
|
299
|
0
|
0
|
0
|
|
Part A
NOT COMPLETED
|
4
|
1
|
5
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
97
|
99
|
297
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
95
|
94
|
289
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
2
|
5
|
8
|
Reasons for withdrawal
| Measure |
Placebo (Part A)
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Ustekinumab (Part A)
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Placebo/Risankizumab (Part B)
Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Ustekinumab/Ustekinumab (Part B)
Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Risankizumab/Risankizumab (Part B)
Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|---|---|
|
Part A
Adverse Event
|
2
|
0
|
1
|
0
|
0
|
0
|
|
Part A
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Part A
Subject Withdrawal
|
1
|
0
|
3
|
0
|
0
|
0
|
|
Part A
Other
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part B
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Part B
Lost to Follow-up
|
0
|
0
|
0
|
1
|
2
|
5
|
|
Part B
Subject Withdrawal
|
0
|
0
|
0
|
1
|
1
|
2
|
Baseline Characteristics
BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo (Part A)
n=102 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Ustekinumab (Part A)
n=100 Participants
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Total
n=506 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 13.63 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 13.42 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 13.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
361 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
459 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
345 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: ITT population
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=102 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
|
4.9 percentage of participants
|
75.3 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: ITT population
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=102 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
|
7.8 percentage of participants
|
87.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=102 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
|
2.0 percentage of participants
|
36.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=102 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
|
0 percentage of participants
|
35.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population
DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired.). A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=102 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
|
7.8 percentage of participants
|
65.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population
The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=102 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
|
2.0 percentage of participants
|
29.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=100 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving PASI90 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
|
42.0 percentage of participants
|
75.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=100 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
|
63.0 percentage of participants
|
87.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=100 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
|
12.0 percentage of participants
|
35.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=100 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
|
14.0 percentage of participants
|
36.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=100 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving PASI90 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)
|
44.0 percentage of participants
|
81.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=100 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving PASI100 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)
|
21.0 percentage of participants
|
56.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=100 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving sPGA Score of Clear at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)
|
21.0 percentage of participants
|
57.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT population
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=100 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving PASI75 at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
|
70.0 percentage of participants
|
86.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT population
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=100 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
|
65.0 percentage of participants
|
82.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population
DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired.). A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=100 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
|
43.0 percentage of participants
|
65.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT population. Last observation carried forward. Participants randomized to placebo or risankizumab with an observed baseline PSS and at least one post-baseline PSS observation on or prior to Week 16.
The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. A negative change from Baseline indicates improvement. Last observation carried forward (LOCF) imputation was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=83 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=251 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
PSS Total Score: Change From Baseline to Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
|
0.157 units on a scale
Standard Error 0.3476
|
-5.608 units on a scale
Standard Error 0.2254
|
Adverse Events
Placebo (Part A)
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Ustekinumab (Part A)
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
Risankizumab (Part A)
Serious events: 7 serious events
Other events: 45 other events
Deaths: 0 deaths
Placebo/Risankizumab (Part B)
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Ustekinumab/Ustekinumab (Part B)
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
Risankizumab/Risankizumab (Part B)
Serious events: 16 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Part A)
n=102 participants at risk
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Ustekinumab (Part A)
n=100 participants at risk
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 participants at risk
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Placebo/Risankizumab (Part B)
n=97 participants at risk
Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Ustekinumab/Ustekinumab (Part B)
n=99 participants at risk
Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Risankizumab/Risankizumab (Part B)
n=297 participants at risk
Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.98%
1/102 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.98%
1/102 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/97 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/99 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/97 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/97 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/99 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/97 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/97 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.98%
1/102 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/97 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/99 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/99 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.98%
1/102 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/99 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/297 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/102 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/99 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
Other adverse events
| Measure |
Placebo (Part A)
n=102 participants at risk
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Ustekinumab (Part A)
n=100 participants at risk
Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=304 participants at risk
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Placebo/Risankizumab (Part B)
n=97 participants at risk
Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Ustekinumab/Ustekinumab (Part B)
n=99 participants at risk
Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Risankizumab/Risankizumab (Part B)
n=297 participants at risk
Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
2/102 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
6.0%
6/100 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
5.6%
17/304 • Number of events 20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
8.2%
8/97 • Number of events 10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
11.1%
11/99 • Number of events 14 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
10.1%
30/297 • Number of events 32 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.98%
1/102 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
5.1%
5/99 • Number of events 5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
3/297 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.9%
6/102 • Number of events 7 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
6.0%
6/100 • Number of events 8 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
6.6%
20/304 • Number of events 24 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
15.5%
15/97 • Number of events 17 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
18.2%
18/99 • Number of events 20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
13.5%
40/297 • Number of events 45 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Nervous system disorders
Headache
|
2.0%
2/102 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
3.0%
9/304 • Number of events 9 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
3.1%
3/97 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
5.1%
5/99 • Number of events 5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.7%
5/297 • Number of events 5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
5.9%
6/102 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.00%
0/97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.0%
1/99 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.34%
1/297 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER