Trial Outcomes & Findings for BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT02694523)
NCT ID: NCT02694523
Last Updated: 2021-07-30
Results Overview
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
684 participants
Primary outcome timeframe
Week 16
Results posted on
2021-07-30
Participant Flow
A total of 684 subjects were enrolled; 79 subjects failed screening and are excluded from the analyses.
Participant milestones
| Measure |
Adalimumab (Part A)
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (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).
|
Risankizumab/Risankizumab (Part B)
Participants randomized to receive double-blind (DB) risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, and 28 (Part B).
|
Adalimumab/Adalimumab (Part B)
Participants who were responders after receiving adalimumab in Part A continued to receive adalimumab 40 mg by subcutaneous (SC) injection every other week through Week 41 (Part B).
|
Adalimumab/Risankizumab (Part B)
Participants who were nonresponders after receiving adalimumab in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
|
Adalimumab/Rerandomized to Adalimumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A and rerandomized to continue to receive adalimumab 40 mg by subcutaneous (SC) injection every 2 weeks through Week 41 (Part B).
|
Adalimumab/Rerandomized to Risankizumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A and rerandomized to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
|
|---|---|---|---|---|---|---|---|
|
Part A
STARTED
|
304
|
301
|
0
|
0
|
0
|
0
|
0
|
|
Part A
COMPLETED
|
291
|
294
|
0
|
0
|
0
|
0
|
0
|
|
Part A
NOT COMPLETED
|
13
|
7
|
0
|
0
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
294
|
144
|
38
|
56
|
53
|
|
Part B
COMPLETED
|
0
|
0
|
274
|
140
|
34
|
51
|
51
|
|
Part B
NOT COMPLETED
|
0
|
0
|
20
|
4
|
4
|
5
|
2
|
Reasons for withdrawal
| Measure |
Adalimumab (Part A)
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (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).
|
Risankizumab/Risankizumab (Part B)
Participants randomized to receive double-blind (DB) risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, and 28 (Part B).
|
Adalimumab/Adalimumab (Part B)
Participants who were responders after receiving adalimumab in Part A continued to receive adalimumab 40 mg by subcutaneous (SC) injection every other week through Week 41 (Part B).
|
Adalimumab/Risankizumab (Part B)
Participants who were nonresponders after receiving adalimumab in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
|
Adalimumab/Rerandomized to Adalimumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A and rerandomized to continue to receive adalimumab 40 mg by subcutaneous (SC) injection every 2 weeks through Week 41 (Part B).
|
Adalimumab/Rerandomized to Risankizumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A and rerandomized to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
|
|---|---|---|---|---|---|---|---|
|
Part A
Adverse Event
|
7
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Part A
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A
Lost to Follow-up
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Part A
Withdrawal by Subject
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part A
Other
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part B
Adverse Event
|
0
|
0
|
7
|
1
|
1
|
2
|
0
|
|
Part B
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part B
Lost to Follow-up
|
0
|
0
|
2
|
3
|
2
|
0
|
1
|
|
Part B
Withdrawal by Subject
|
0
|
0
|
9
|
0
|
1
|
3
|
0
|
|
Part B
Other
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
Baseline Characteristics
BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Adalimumab (Part A)
n=304 Participants
Participants randomized to receive double blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Weeks 0, 1, and every other week for 15 weeks (Part A).
|
Risankizumab (Part A)
n=301 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4 (Part A).
|
Total
n=605 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.0 years
STANDARD_DEVIATION 13.09 • n=99 Participants
|
45.3 years
STANDARD_DEVIATION 13.79 • n=107 Participants
|
46.2 years
STANDARD_DEVIATION 13.46 • n=206 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
183 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
212 Participants
n=99 Participants
|
210 Participants
n=107 Participants
|
422 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
59 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
245 Participants
n=99 Participants
|
257 Participants
n=107 Participants
|
502 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
263 Participants
n=99 Participants
|
245 Participants
n=107 Participants
|
508 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Intent-to-treat population in Part A (ITT\_A): All subjects randomized at Baseline.
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Adalimumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
|
Risankizumab (Part A)
n=301 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 (Part A)
|
47.4 percentage of participants
|
72.4 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: ITT\_A 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 |
Adalimumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
|
Risankizumab (Part A)
n=301 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
|---|---|---|
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)
|
60.2 percentage of participants
|
83.7 percentage of participants
|
PRIMARY outcome
Timeframe: Week 44Population: Intent-to-treat population in Part B who were re-randomized (ITT\_B\_RR): All subjects who started with adalimumab at Baseline and were re-randomized at Week 16
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 |
Adalimumab (Part A)
n=56 Participants
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
|
Risankizumab (Part A)
n=53 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 Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B)
|
21.4 percentage of participants
|
66.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT\_A 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 |
Adalimumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
|
Risankizumab (Part A)
n=301 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 (Part A)
|
71.7 percentage of participants
|
90.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT\_A 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 |
Adalimumab (Part A)
n=304 Participants
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
|
Risankizumab (Part A)
n=301 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 (Part A)
|
23.0 percentage of participants
|
39.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 44Population: ITT\_B\_RR 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 |
Adalimumab (Part A)
n=56 Participants
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
|
Risankizumab (Part A)
n=53 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 Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI100 at Week 44 (Part B)
|
7.1 percentage of participants
|
39.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 44Population: ITT\_B\_RR 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 |
Adalimumab (Part A)
n=56 Participants
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
|
Risankizumab (Part A)
n=53 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 Who Were ReRandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear at Week 44 (Part B)
|
7.1 percentage of participants
|
39.6 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 44Population: ITT\_B\_RR 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 |
Adalimumab (Part A)
n=56 Participants
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
|
Risankizumab (Part A)
n=53 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 Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear or Almost Clear at Week 44 (Part B)
|
33.9 percentage of participants
|
73.6 percentage of participants
|
Adverse Events
Adalimumab (Part A)
Serious events: 9 serious events
Other events: 71 other events
Deaths: 2 deaths
Risankizumab (Part A)
Serious events: 10 serious events
Other events: 76 other events
Deaths: 1 deaths
Risankizumab/Risankizumab (Part B)
Serious events: 12 serious events
Other events: 95 other events
Deaths: 0 deaths
Adalimumab/Risankizumab (Part B)
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Adalimumab/Rerandomized to Adalimumab (Part B)
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Adalimumab/Rerandomized to Risankizumab (Part B)
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab (Part A)
n=304 participants at risk
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
|
Risankizumab (Part A)
n=301 participants at risk
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab/Risankizumab (Part B)
n=294 participants at risk
Participants randomized to receive double-blind (DB) risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, and 28 (Part B).
|
Adalimumab/Risankizumab (Part B)
n=38 participants at risk
Participants who were nonresponders after receiving adalimumab in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
|
Adalimumab/Rerandomized to Adalimumab (Part B)
n=56 participants at risk
Participants who were inadequate responders after receiving adalimumab in Part A and re-randomized to continue to receive adalimumab 40 mg by subcutaneous (SC) injection every 2 weeks through Week 41 (Part B).
|
Adalimumab/Rerandomized to Risankizumab (Part B)
n=53 participants at risk
Participants who were inadequate responders after receiving adalimumab in Part A and re-randomized to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.33%
1/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
2.6%
1/38 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
1.8%
1/56 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Congenital, familial and genetic disorders
Macrocornea
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.33%
1/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Eye disorders
Macular hole
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
2.6%
1/38 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.33%
1/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Infections and infestations
Abdominal abscess
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
5.3%
2/38 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
1.9%
1/53 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.33%
1/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
2.6%
1/38 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
2.6%
1/38 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
1.9%
1/53 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
1.9%
1/53 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.33%
1/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.33%
1/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
2.6%
1/38 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
1.8%
1/56 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.33%
1/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
2.6%
1/38 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.33%
1/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.33%
1/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.33%
1/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.33%
1/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.33%
1/304 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
Other adverse events
| Measure |
Adalimumab (Part A)
n=304 participants at risk
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
|
Risankizumab (Part A)
n=301 participants at risk
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab/Risankizumab (Part B)
n=294 participants at risk
Participants randomized to receive double-blind (DB) risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, and 28 (Part B).
|
Adalimumab/Risankizumab (Part B)
n=38 participants at risk
Participants who were nonresponders after receiving adalimumab in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
|
Adalimumab/Rerandomized to Adalimumab (Part B)
n=56 participants at risk
Participants who were inadequate responders after receiving adalimumab in Part A and re-randomized to continue to receive adalimumab 40 mg by subcutaneous (SC) injection every 2 weeks through Week 41 (Part B).
|
Adalimumab/Rerandomized to Risankizumab (Part B)
n=53 participants at risk
Participants who were inadequate responders after receiving adalimumab in Part A and re-randomized to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
0.99%
3/304 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
1.3%
4/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
2.4%
7/294 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
5.3%
2/38 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
5.4%
3/56 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
3.8%
2/53 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
12/304 • Number of events 15 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
7.0%
21/301 • Number of events 26 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
11.6%
34/294 • Number of events 44 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
7.9%
3/38 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
8.9%
5/56 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
7.5%
4/53 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.9%
24/304 • Number of events 29 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
8.6%
26/301 • Number of events 31 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
13.3%
39/294 • Number of events 48 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
23.7%
9/38 • Number of events 14 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
12.5%
7/56 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
26.4%
14/53 • Number of events 19 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
9/304 • Number of events 12 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
3.7%
11/301 • Number of events 12 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
1.4%
4/294 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
5.4%
3/56 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
3.8%
2/53 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
6/304 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
3.0%
9/301 • Number of events 9 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
5.4%
3/56 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
3.8%
2/53 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/304 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/301 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.68%
2/294 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
5.3%
2/38 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Nervous system disorders
Headache
|
6.6%
20/304 • Number of events 29 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
4.0%
12/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
2.0%
6/294 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
5.3%
2/38 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
5.4%
3/56 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
5.7%
3/53 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.99%
3/304 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
2.0%
6/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
1.0%
3/294 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
5.3%
2/38 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
1.8%
1/56 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
3.8%
2/53 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
|
Vascular disorders
Hypertension
|
2.6%
8/304 • Number of events 12 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
0.33%
1/301 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
3.1%
9/294 • Number of events 9 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
7.9%
3/38 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
1.8%
1/56 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks after the last dose of study drug.
|
1.9%
1/53 • 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 48 weeks).
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks 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 15 weeks 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