Trial Outcomes & Findings for BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment (NCT NCT02672852)
NCT ID: NCT02672852
Last Updated: 2019-10-09
Results Overview
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Non-responder imputation (NRI) was used for missing data.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
507 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2019-10-09
Participant Flow
Part A1: double-blind (DB) risankizumab or placebo (Weeks 0,4). Part A2 (Week 16) DB placebo to DB risankizumab; risankizumab continued risankizumab. Part B (Week 28) risankizumab responders rerandomized to DB risankizumab/placebo; risankizumab nonresponders continued risankizumab. Week 32: rerandomized relapsed switch risankizumab.
Participant milestones
| Measure |
Placebo (Part A1)
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
Placebo/Risankizumab Part A2/Part B
Participants randomized at Baseline to receive double-blind (DB) placebo then received DB risankizumab 150 mg at Weeks 16 (Part A2) and at Week 28 and every 12 weeks up to 88 weeks (Part B).
|
Risankizumab/Risankizumab Part A2
Participants randomized at Baseline to receive double-blind (DB) risankizumab then received DB risankizumab 150 mg at Weeks 16 (Part A2).
|
Risankizumab/Placebo (Part B; Rerandomized Responders)
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B).
|
Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B).
|
Risankizumab/Risankizumab Part B (Nonresponders)
Participants who received risankizumab in Part A and were nonresponders (sPGA ≥2) at Week 28 received risankizumab 150 mg at Week 28 and every 12 weeks up to 88 weeks (Part B).
|
|---|---|---|---|---|---|---|---|
|
Part A1
STARTED
|
100
|
407
|
0
|
0
|
0
|
0
|
0
|
|
Part A1
COMPLETED
|
97
|
403
|
0
|
0
|
0
|
0
|
0
|
|
Part A1
NOT COMPLETED
|
3
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Part A2
STARTED
|
0
|
0
|
93
|
403
|
0
|
0
|
0
|
|
Part A2
COMPLETED
|
0
|
0
|
83
|
399
|
0
|
0
|
0
|
|
Part A2
NOT COMPLETED
|
0
|
0
|
10
|
4
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
0
|
225
|
111
|
63
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
0
|
209
|
100
|
51
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
16
|
11
|
12
|
Reasons for withdrawal
| Measure |
Placebo (Part A1)
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
Placebo/Risankizumab Part A2/Part B
Participants randomized at Baseline to receive double-blind (DB) placebo then received DB risankizumab 150 mg at Weeks 16 (Part A2) and at Week 28 and every 12 weeks up to 88 weeks (Part B).
|
Risankizumab/Risankizumab Part A2
Participants randomized at Baseline to receive double-blind (DB) risankizumab then received DB risankizumab 150 mg at Weeks 16 (Part A2).
|
Risankizumab/Placebo (Part B; Rerandomized Responders)
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B).
|
Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B).
|
Risankizumab/Risankizumab Part B (Nonresponders)
Participants who received risankizumab in Part A and were nonresponders (sPGA ≥2) at Week 28 received risankizumab 150 mg at Week 28 and every 12 weeks up to 88 weeks (Part B).
|
|---|---|---|---|---|---|---|---|
|
Part A1
Disease Worsening
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A1
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part A1
Lost to Follow-up
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Part A1
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part A2
Disease worsening
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part A2
Adverse Event
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Part A2
Lost to Follow-up
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Part A2
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part A2
Other
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Part A2
Not entered in Part B
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
|
Part B
Disease worsening
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Part B
Worsening pre-existing condition
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part B
Other adverse event
|
0
|
0
|
0
|
0
|
3
|
5
|
1
|
|
Part B
Lost to Follow-up
|
0
|
0
|
0
|
0
|
3
|
4
|
1
|
|
Part B
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
5
|
0
|
7
|
|
Part B
Other
|
0
|
0
|
0
|
0
|
4
|
1
|
2
|
Baseline Characteristics
BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment
Baseline characteristics by cohort
| Measure |
Placebo (Part A1)
n=100 Participants
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
n=407 Participants
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
Total
n=507 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 13.78 • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 13.17 • n=7 Participants
|
49.2 years
STANDARD_DEVIATION 13.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
283 Participants
n=7 Participants
|
356 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=5 Participants
|
362 Participants
n=7 Participants
|
451 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
320 Participants
n=7 Participants
|
402 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: Intent to treat (ITT) Population in Part A1(ITT\_A1): all participants who were 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. Non-responder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A1)
n=100 Participants
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
n=407 Participants
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
|---|---|---|
|
Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16
|
2.0 percentage of participants
|
73.2 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: ITT Population in Part A1(ITT\_A1)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A1)
n=100 Participants
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
n=407 Participants
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
|---|---|---|
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16
|
7.0 percentage of participants
|
83.5 percentage of participants
|
PRIMARY outcome
Timeframe: Week 52Population: ITT Population in Part B for re-randomized participants (ITT\_B\_R): All participants who were randomized to Arm 1 at Baseline and re randomized at Week 28.
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A1)
n=225 Participants
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
n=111 Participants
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
|---|---|---|
|
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52
|
61.3 percentage of participants
|
87.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT Population in Part A1 (ITT\_A1)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A1)
n=100 Participants
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
n=407 Participants
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
|---|---|---|
|
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16
|
8.0 percentage of participants
|
88.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT Population in Part A1 (ITT\_A1)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A1)
n=100 Participants
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
n=407 Participants
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
|---|---|---|
|
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16
|
1.0 percentage of participants
|
47.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT Population in Part A1 (ITT\_A1)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A1)
n=100 Participants
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
n=407 Participants
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
|---|---|---|
|
Percentage of Participants Achieving an sPGA Score of Clear at Week 16
|
1.0 percentage of participants
|
46.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT Population in Part A1 (ITT\_A1)
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A1)
n=100 Participants
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
n=407 Participants
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
|---|---|---|
|
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
|
3.0 percentage of participants
|
65.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 104Population: ITT Population in Part B for re-randomized participants (ITT\_B\_R)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A1)
n=225 Participants
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
n=111 Participants
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
|---|---|---|
|
Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104
|
7.1 percentage of participants
|
81.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population in Part B for re-randomized participants (ITT\_B\_R)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A1)
n=225 Participants
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
n=111 Participants
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
|---|---|---|
|
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52
|
71.6 percentage of participants
|
92.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population in Part B for re-randomized participants (ITT\_B\_R)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A1)
n=225 Participants
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
n=111 Participants
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
|---|---|---|
|
Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52
|
52.4 percentage of participants
|
85.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population in Part B for re-randomized participants (ITT\_B\_R)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
Outcome measures
| Measure |
Placebo (Part A1)
n=225 Participants
Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
n=111 Participants
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
|---|---|---|
|
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52
|
30.2 percentage of participants
|
64.0 percentage of participants
|
Adverse Events
Placebo (Part A1)
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
Risankizumab (Part A1)
Serious events: 8 serious events
Other events: 52 other events
Deaths: 0 deaths
Risankizumab/Placebo (Part B; Rerandomized Responders)
Serious events: 17 serious events
Other events: 92 other events
Deaths: 0 deaths
Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Serious events: 13 serious events
Other events: 52 other events
Deaths: 2 deaths
Any Risankizumab
Serious events: 55 serious events
Other events: 242 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Placebo (Part A1)
n=100 participants at risk
All participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
n=407 participants at risk
All participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
Risankizumab/Placebo (Part B; Rerandomized Responders)
n=225 participants at risk
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B).
|
Risankizumab/Risankizumab (Part B; Rerandomized Responders)
n=111 participants at risk
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B).
|
Any Risankizumab
n=500 participants at risk
Participants who received at least one dose of risankizumab during the study.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.40%
2/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.25%
1/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Congenital, familial and genetic disorders
Benign familial pemphigus
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Congenital, familial and genetic disorders
Huntington's disease
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Eye disorders
Retinal detachment
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
General disorders
Death
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.25%
1/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.40%
2/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Hepatobiliary disorders
Liver injury
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Infections and infestations
Abscess neck
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.25%
1/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Infections and infestations
Cellulitis
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.40%
2/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Infections and infestations
Sepsis
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.40%
2/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Infections and infestations
Viral infection
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.40%
2/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Injury, poisoning and procedural complications
Open globe injury
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.25%
1/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.25%
1/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.25%
1/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Musculoskeletal and connective tissue disorders
Gouty tophus
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Musculoskeletal and connective tissue disorders
Jaw cyst
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.40%
2/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.60%
3/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.25%
1/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.25%
1/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.89%
2/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.40%
2/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.25%
1/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.40%
2/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Nervous system disorders
Basal ganglia infarction
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Nervous system disorders
Dementia
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.40%
2/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Nervous system disorders
Seizure
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Nervous system disorders
Tension headache
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Nervous system disorders
Transient ischaemic attack
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Psychiatric disorders
Alcoholism
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Psychiatric disorders
Delirium tremens
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Psychiatric disorders
Insomnia
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Psychiatric disorders
Somatic symptom disorder
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Psychiatric disorders
Suicidal ideation
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.90%
1/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.44%
1/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.25%
1/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.25%
1/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.20%
1/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/407 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/225 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/500 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
Other adverse events
| Measure |
Placebo (Part A1)
n=100 participants at risk
All participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1).
|
Risankizumab (Part A1)
n=407 participants at risk
All participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1).
|
Risankizumab/Placebo (Part B; Rerandomized Responders)
n=225 participants at risk
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B).
|
Risankizumab/Risankizumab (Part B; Rerandomized Responders)
n=111 participants at risk
Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B).
|
Any Risankizumab
n=500 participants at risk
Participants who received at least one dose of risankizumab during the study.
|
|---|---|---|---|---|---|
|
Infections and infestations
Influenza
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.74%
3/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
3.6%
8/225 • Number of events 10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
6.3%
7/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
4.4%
22/500 • Number of events 24 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
6/100 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
5.2%
21/407 • Number of events 21 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
20.0%
45/225 • Number of events 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
20.7%
23/111 • Number of events 36 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
23.2%
116/500 • Number of events 170 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
5/100 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
1.5%
6/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
10.2%
23/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
14.4%
16/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
15.4%
77/500 • Number of events 97 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
1.7%
7/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
5.8%
13/225 • Number of events 16 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
9.0%
10/111 • Number of events 10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
7.0%
35/500 • Number of events 37 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.49%
2/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
5.3%
12/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
3.6%
4/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
5.6%
28/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Nervous system disorders
Headache
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
3.4%
14/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
3.1%
7/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
7.2%
8/111 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
6.8%
34/500 • Number of events 47 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
5.0%
5/100 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.49%
2/407 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
3.6%
8/225 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.00%
0/111 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
0.80%
4/500 • 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 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at \[up to Week 103\]).
|
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