Trial Outcomes & Findings for BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT02684357)
NCT ID: NCT02684357
Last Updated: 2021-08-23
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. Non-responder imputation (NRI) was used for missing data.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
577 participants
Primary outcome timeframe
Week 16
Results posted on
2021-08-23
Participant Flow
A total of 577 subjects were enrolled; 86 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 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
|
98
|
99
|
294
|
0
|
0
|
0
|
|
Part A
COMPLETED
|
94
|
96
|
292
|
0
|
0
|
0
|
|
Part A
NOT COMPLETED
|
4
|
3
|
2
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
94
|
94
|
291
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
91
|
90
|
278
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
3
|
4
|
13
|
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 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 (Worsening of Disease)
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part A
Lost to Follow-up
|
0
|
2
|
2
|
0
|
0
|
0
|
|
Part A
Withdrawal by Subject
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Part A
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part B
Adverse Event (Other)
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Part B
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
7
|
|
Part B
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
4
|
|
Part B
Other
|
0
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo (Part A)
n=98 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Ustekinumab (Part A)
n=99 Participants
Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Total
n=491 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 13.26 • n=93 Participants
|
48.6 years
STANDARD_DEVIATION 14.81 • n=4 Participants
|
46.2 years
STANDARD_DEVIATION 13.68 • n=27 Participants
|
46.7 years
STANDARD_DEVIATION 13.84 • n=483 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
155 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
203 Participants
n=27 Participants
|
336 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
75 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
250 Participants
n=27 Participants
|
416 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=93 Participants
|
91 Participants
n=4 Participants
|
255 Participants
n=27 Participants
|
433 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Intent-to-treat (ITT) population: all randomized participants.
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. Non-responder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=98 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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)
|
2.0 percentage of participants
|
74.8 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=98 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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 a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
|
5.1 percentage of participants
|
83.7 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=98 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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)
|
3.1 percentage of participants
|
51.0 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=98 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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)
|
2.0 percentage of participants
|
50.7 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=98 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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 a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
|
4.1 percentage of participants
|
66.7 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 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=98 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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 a Psoriasis Symptom Scale (PSS) Score of 0 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
|
0 percentage of participants
|
31.3 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. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=99 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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)
|
47.5 percentage of participants
|
74.8 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=99 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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)
|
61.6 percentage of participants
|
83.7 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. PASI00 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=99 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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)
|
24.2 percentage of participants
|
50.7 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=99 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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)
|
25.3 percentage of participants
|
51.0 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. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=99 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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)
|
50.5 percentage of participants
|
80.6 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. PASI00 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=99 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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)
|
30.3 percentage of participants
|
59.5 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=99 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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)
|
30.3 percentage of participants
|
59.5 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 75% 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=99 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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)
|
69.7 percentage of participants
|
88.8 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=99 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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)
|
64.6 percentage of participants
|
82.3 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=99 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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 a DLQI Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)
|
46.5 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: 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 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 in PSS total score indicates improvement. Last observation carried forward (LOCF) imputation was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=85 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=227 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Change From Baseline to Week 16 in PSS Total Score in Participants Who Received Risankizumab Compared With Placebo (Part A)
|
-0.027 units on a scale
Standard Error 0.3316
|
-6.402 units on a scale
Standard Error 0.2193
|
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. PASI75 is defined as at least a 75% 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=98 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
|
6.1 percentage of participants
|
90.8 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.
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=99 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)
|
54.5 percentage of participants
|
83.3 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.
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 75% 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=99 Participants
Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)
|
76.8 percentage of participants
|
91.5 percentage of participants
|
Adverse Events
Placebo (Part A)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Ustekinumab (Part A)
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Risankizumab (Part A)
Serious events: 6 serious events
Other events: 29 other events
Deaths: 1 deaths
Placebo/Risankizumab (Part B)
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Ustekinumab/Ustekinumab (Part B)
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Risankizumab/Risankizumab (Part B)
Serious events: 13 serious events
Other events: 67 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo (Part A)
n=98 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=99 participants at risk
Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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=94 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=94 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=291 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
Atrial fibrillation
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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
Atrial flutter
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.1%
1/94 • 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; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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
Cardiac aneurysm
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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
Cardiac failure congestive
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
1/294 • 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; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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
Cardiac ventricular thrombosis
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
1/294 • 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; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.1%
1/94 • 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; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Eye disorders
Glaucoma
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.1%
1/94 • 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; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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
Colitis
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.1%
1/94 • 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; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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
Enterovesical fistula
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
1/294 • 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; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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
Gastric dilatation
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
1/294 • 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; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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
Hiatus hernia
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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
Non-cardiac chest pain
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
1/294 • 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; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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
Diverticulitis
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
1/294 • 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; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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
Herpes zoster
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
1/294 • 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; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
1/294 • 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; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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
Pneumonia
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
0.69%
2/291 • 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; AEs in Part B are defined as events 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%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
1/294 • 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; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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
Fall
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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
Fibula fracture
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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
Meniscus injury
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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
Tibia fracture
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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
Muscular weakness
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.1%
1/94 • 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; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
1/294 • 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; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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)
Breast cancer
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.1%
1/94 • 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; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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)
Prostate cancer
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.1%
1/94 • 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; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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
Seizure
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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
Transient ischaemic attack
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.1%
1/94 • 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; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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
Menometrorrhagia
|
1.0%
1/98 • 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; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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
Respiratory failure
|
0.00%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
1/291 • 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; AEs in Part B are defined as events 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%
0/98 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
0/294 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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%
0/291 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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=98 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=99 participants at risk
Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab (Part A)
n=294 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=94 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=94 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=291 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).
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
3/98 • 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; AEs in Part B are defined as events 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 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; AEs in Part B are defined as events 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%
3/294 • 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; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
2.1%
2/94 • 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; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
3.2%
3/94 • 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; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
2.1%
6/291 • 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; AEs in Part B are defined as events 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
Influenza
|
1.0%
1/98 • 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; AEs in Part B are defined as events 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; AEs in Part B are defined as events 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%
6/294 • 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; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
2.1%
2/94 • 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; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
5.3%
5/94 • 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; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
1.4%
4/291 • 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; AEs in Part B are defined as events 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
Upper respiratory tract infection
|
2.0%
2/98 • 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; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
4.0%
4/99 • 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; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
3.7%
11/294 • Number of events 11 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
9.6%
9/94 • Number of events 13 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
8.5%
8/94 • 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; AEs in Part B are defined as events 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%
24/291 • Number of events 28 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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
|
2.0%
2/98 • 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; AEs in Part B are defined as events 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; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
3.4%
10/294 • 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; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
18.1%
17/94 • Number of events 22 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
14.9%
14/94 • Number of events 16 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 105 days after the last dose of study drug.
|
11.7%
34/291 • Number of events 40 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).
TEAEs and TESAEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 105 days after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events 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