Trial Outcomes & Findings for A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease (NCT NCT03105128)
NCT ID: NCT03105128
Last Updated: 2022-07-06
Results Overview
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
931 participants
Primary outcome timeframe
Week 12
Results posted on
2022-07-06
Participant Flow
Subjects were randomized to receive 600mg risankizumab, 1200mg risankizumab or placebo during the double-blind, placebo-controlled Period 1. At Week 12, subjects who do not achieve clinical response were randomized into Period 2 to receive 180mg risankizumab, 360mg risankizumab or 1200mg risankizumab. Subjects who received placebo received 1200mg.
A total of 931 subjects were enrolled and included in the intent-to-treat (ITT) population; 850 of those had a baseline eligible Simple Endoscopic Score for Crohn's disease (SES-CD) of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component and were included in the ITT1A population. This population was the primary population for both the United States (US) specific as well as the Global (Outside the US) efficacy analysis' of the 12-Week Induction Period.
Participant milestones
| Measure |
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Placebo (Induction Period 1)
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 180mg (Induction Period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Period 2
|
Risankizumab 360mg (Induction Period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Period 2.
risankizumab SC: Risankizumab administered by subcutaneous (SC) injection
|
Risankizumab 1200mg (Induction Period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab 1200mg administered by intravenous infusion (IV) in Period 2.
risankizumab IV: Risankizumab administered by intravenous infusion (IV)
|
Placebo/Risankizumab IV (Induction Period 2)
Participants who received placebo in Induction Period 1 received 1200 mg risankizumab by intravenous infusion (IV) at Weeks 12, 16, and 20.
risankizumab IV: Risankizumab administered by intravenous infusion (IV)
|
|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
373
|
372
|
186
|
0
|
0
|
0
|
0
|
|
Period 1
COMPLETED
|
365
|
366
|
163
|
0
|
0
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
8
|
6
|
23
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
0
|
0
|
0
|
67
|
68
|
67
|
76
|
|
Period 2
COMPLETED
|
0
|
0
|
0
|
62
|
65
|
64
|
74
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
5
|
3
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
Risankizumab 600mg (Period 1)
n=373 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=372 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Placebo (Period 1)
n=186 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Total
n=931 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
291 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
714 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
355 Participants
n=5 Participants
|
350 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
880 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 13.22 • n=5 Participants
|
37.6 years
STANDARD_DEVIATION 13.55 • n=7 Participants
|
37.5 years
STANDARD_DEVIATION 13.51 • n=5 Participants
|
37.9 years
STANDARD_DEVIATION 13.40 • n=4 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
434 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
205 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
497 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
360 Participants
n=5 Participants
|
354 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
890 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
68 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1, and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
|
24.6 percentage of participants
Interval 18.2 to 31.0
|
45.2 percentage of participants
Interval 39.9 to 50.5
|
41.6 percentage of participants
Interval 36.3 to 46.8
|
PRIMARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1, and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Endoscopic Response
|
12.0 percentage of participants
Interval 7.2 to 16.8
|
40.3 percentage of participants
Interval 35.0 to 45.6
|
32.1 percentage of participants
Interval 27.1 to 37.1
|
PRIMARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Clinical Remission
|
21.7 percentage of participants
Interval 15.6 to 27.8
|
43.5 percentage of participants
Interval 38.2 to 48.8
|
41.0 percentage of participants
Interval 35.8 to 46.2
|
PRIMARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Endoscopic Response
|
12.0 percentage of participants
Interval 7.2 to 16.8
|
40.3 percentage of participants
Interval 35.0 to 45.6
|
32.1 percentage of participants
Interval 27.1 to 37.1
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1, and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Clinical Remission
|
21.7 percentage of participants
Interval 15.6 to 27.8
|
43.5 percentage of participants
Interval 38.2 to 48.8
|
41.0 percentage of participants
Interval 35.8 to 46.2
|
SECONDARY outcome
Timeframe: Week 4Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1, and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
|
25.2 percentage of participants
Interval 18.7 to 31.6
|
40.8 percentage of participants
Interval 35.5 to 46.0
|
37.2 percentage of participants
Interval 32.0 to 42.3
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1, and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
|
36.7 percentage of participants
Interval 29.6 to 43.9
|
59.7 percentage of participants
Interval 54.5 to 65.0
|
64.9 percentage of participants
Interval 59.8 to 70.0
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1, and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo (Period 1)
n=134 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=302 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=310 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
|
6.0 percentage of participants
Interval 4.4 to 7.7
|
11.2 percentage of participants
Interval 10.1 to 12.4
|
10.1 percentage of participants
Interval 9.0 to 11.3
|
SECONDARY outcome
Timeframe: Week 4Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1, and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
|
10.3 percentage of participants
Interval 5.8 to 14.8
|
18.4 percentage of participants
Interval 14.3 to 22.6
|
18.9 percentage of participants
Interval 14.7 to 23.0
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline. Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) \> 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response
|
5.7 percentage of participants
Interval 2.3 to 9.2
|
30.0 percentage of participants
Interval 25.1 to 34.9
|
23.0 percentage of participants
Interval 18.5 to 27.5
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1, and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Stool Frequency (SF) remission is defined as an average daily SF \<= 2.8 and not worse than baseline.
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Stool Frequency (SF) Remission
|
29.8 percentage of participants
Interval 23.1 to 36.6
|
54.2 percentage of participants
Interval 48.8 to 59.5
|
54.0 percentage of participants
Interval 48.7 to 59.3
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. AP remission is defined as average daily AP score \<= 1 and not worse than baseline.
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Abdominal Pain (AP) Remission
|
38.5 percentage of participants
Interval 31.2 to 45.7
|
59.6 percentage of participants
Interval 54.3 to 64.8
|
58.1 percentage of participants
Interval 52.9 to 63.4
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Endoscopic Remission
|
9.1 percentage of participants
Interval 4.9 to 13.4
|
24.2 percentage of participants
Interval 19.6 to 28.7
|
23.9 percentage of participants
Interval 19.4 to 28.5
|
SECONDARY outcome
Timeframe: Week 4Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Enhanced Clinical Response
|
31.0 percentage of participants
Interval 24.1 to 37.9
|
46.0 percentage of participants
Interval 40.7 to 51.3
|
43.4 percentage of participants
Interval 38.1 to 48.6
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1, and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Outcome measures
| Measure |
Placebo (Period 1)
n=173 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Ulcer-Free Endoscopy
|
7.6 percentage of participants
Interval 3.6 to 11.5
|
21.0 percentage of participants
Interval 16.6 to 25.4
|
16.4 percentage of participants
Interval 12.4 to 20.3
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Enhanced Clinical Response
|
41.9 percentage of participants
Interval 34.6 to 49.3
|
62.8 percentage of participants
Interval 57.6 to 68.0
|
64.3 percentage of participants
Interval 59.2 to 69.4
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1, and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Outcome measures
| Measure |
Placebo (Period 1)
n=64 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=140 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=158 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at
|
20.5 percentage of participants
Interval 10.5 to 30.4
|
38.1 percentage of participants
Interval 30.0 to 46.1
|
43.7 percentage of participants
Interval 35.9 to 51.4
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Participants with at least one admission to the hospital due to Crohn's Disease.
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants With CD-Related Hospitalization
|
12.0 percentage of participants
Interval 7.2 to 16.8
|
3.3 percentage of participants
Interval 1.4 to 5.2
|
1.8 percentage of participants
Interval 0.4 to 3.2
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Outcome measures
| Measure |
Placebo (Period 1)
n=9 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=18 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=24 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
|
22.2 percentage of participants
Interval 0.0 to 49.4
|
27.8 percentage of participants
Interval 7.1 to 48.5
|
29.2 percentage of participants
Interval 11.0 to 47.4
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
|
24.6 percentage of participants
Interval 18.2 to 31.0
|
45.2 percentage of participants
Interval 39.9 to 50.5
|
41.6 percentage of participants
Interval 36.3 to 46.8
|
SECONDARY outcome
Timeframe: Week 4Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
|
25.2 percentage of participants
Interval 18.7 to 31.6
|
40.8 percentage of participants
Interval 35.5 to 46.0
|
37.2 percentage of participants
Interval 32.0 to 42.3
|
SECONDARY outcome
Timeframe: Week 4Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Clinical Remission
|
9.1 percentage of participants
Interval 4.9 to 13.4
|
21.0 percentage of participants
Interval 16.6 to 25.3
|
21.2 percentage of participants
Interval 16.9 to 25.6
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
|
36.7 percentage of participants
Interval 29.6 to 43.9
|
59.7 percentage of participants
Interval 54.5 to 65.0
|
64.9 percentage of participants
Interval 59.8 to 70.0
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo (Period 1)
n=134 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=302 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=310 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
|
6.0 units on a scale
Interval 4.4 to 7.7
|
11.2 units on a scale
Interval 10.1 to 12.4
|
10.1 units on a scale
Interval 9.0 to 11.3
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.
Outcome measures
| Measure |
Placebo (Period 1)
n=134 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=302 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=310 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
|
23.6 units on a scale
Interval 18.2 to 28.9
|
44.3 units on a scale
Interval 40.6 to 48.0
|
43.0 units on a scale
Interval 39.4 to 46.6
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Enhanced clinical response was defined as ≥ 60% decrease in average daily Stool Frequency and/or ≥ 35% decrease in average daily Abdominal Pain score and both not worse than baseline, and/or clinical remission. Endoscopic Response was defined as a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) \> 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response
|
8.0 percentage of participants
Interval 4.0 to 12.0
|
30.9 percentage of participants
Interval 25.9 to 35.8
|
23.2 percentage of participants
Interval 18.7 to 27.8
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Endoscopic Remission
|
9.1 percentage of participants
Interval 4.9 to 13.4
|
24.2 percentage of participants
Interval 19.6 to 28.7
|
23.9 percentage of participants
Interval 19.4 to 28.5
|
SECONDARY outcome
Timeframe: Week 4Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
|
31.0 percentage of participants
Interval 24.1 to 37.9
|
46.0 percentage of participants
Interval 40.7 to 51.3
|
43.4 percentage of participants
Interval 38.1 to 48.6
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Outcome measures
| Measure |
Placebo (Period 1)
n=173 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=338 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy
|
7.6 percentage of participants
Interval 3.6 to 11.5
|
21.0 percentage of participants
Interval 16.6 to 25.4
|
16.4 percentage of participants
Interval 12.4 to 20.3
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
|
41.9 percentage of participants
Interval 34.6 to 49.3
|
62.8 percentage of participants
Interval 57.6 to 68.0
|
64.3 percentage of participants
Interval 59.2 to 69.4
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Outcome measures
| Measure |
Placebo (Period 1)
n=64 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=140 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=158 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline
|
20.5 percentage of participants
Interval 10.5 to 30.4
|
38.1 percentage of participants
Interval 30.0 to 46.1
|
43.7 percentage of participants
Interval 35.9 to 51.4
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Participants with at least one admission to the hospital due to Crohn's Disease.
Outcome measures
| Measure |
Placebo (Period 1)
n=175 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=336 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=339 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With CD-Related Hospitalization
|
12.0 percentage of participants
Interval 7.2 to 16.8
|
3.3 percentage of participants
Interval 1.4 to 5.2
|
1.8 percentage of participants
Interval 0.4 to 3.2
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Outcome measures
| Measure |
Placebo (Period 1)
n=9 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=18 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=24 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
|
22.2 percentage of participants
Interval 0.0 to 49.4
|
27.8 percentage of participants
Interval 7.1 to 48.5
|
29.2 percentage of participants
Interval 11.0 to 47.4
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment \[OWI\]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Placebo (Period 1)
n=65 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=156 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=162 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment
|
-8.344 units on a scale
Standard Error 3.5640
|
-17.930 units on a scale
Standard Error 2.3446
|
-20.485 units on a scale
Standard Error 2.3112
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
The Short Form-36 Health Survey determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo (Period 1)
n=134 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion
|
Risankizumab 600mg (Period 1)
n=302 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
Risankizumab 1200mg (Period 1)
n=309 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
risankizumab IV: Risankizumab administered by intravenous infusion
|
|---|---|---|---|
|
Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score
|
5.482 units on a scale
Standard Error 0.5985
|
8.394 units on a scale
Standard Error 0.4107
|
8.756 units on a scale
Standard Error 0.4071
|
Adverse Events
Period 1 Placebo IV
Serious events: 28 serious events
Other events: 35 other events
Deaths: 2 deaths
Period 1 Risankizumab 600mg IV
Serious events: 27 serious events
Other events: 67 other events
Deaths: 0 deaths
Period 1 Risankizumab 1200mg IV
Serious events: 14 serious events
Other events: 58 other events
Deaths: 0 deaths
Period 1 Risankizumab Total
Serious events: 41 serious events
Other events: 125 other events
Deaths: 0 deaths
Period 2 Risankizumab 180mg SC
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Period 2 Risankizumab 360mg SC
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Period 2 Risankizumab 1200mg IV
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Period 2 Placebo/Risankizumab 1200mg IV
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Period 2 Risankizumab Total
Serious events: 14 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1 Placebo IV
n=186 participants at risk
Participants randomized to receive Placebo intravenous (IV) at Baseline, Weeks 4 and 8.
|
Period 1 Risankizumab 600mg IV
n=373 participants at risk
Participants randomized to receive risankizumab 600mg intravenous (IV) at Baseline, Weeks 4 and 8.
|
Period 1 Risankizumab 1200mg IV
n=372 participants at risk
Participants randomized to receive risankizumab 1200mg intravenous (IV) at Baseline, Weeks 4 and 8.
|
Period 1 Risankizumab Total
n=745 participants at risk
Total Period 1 participants randomized into the Risankizumab treatment arm
|
Period 2 Risankizumab 180mg SC
n=67 participants at risk
Participants randomized to receive risankizumab 180mg subcutaneously (SC) at Weeks 12 and 20.
|
Period 2 Risankizumab 360mg SC
n=68 participants at risk
Participants randomized to receive risankizumab 360mg subcutaneously (SC) at Weeks 12 and 20.
|
Period 2 Risankizumab 1200mg IV
n=67 participants at risk
Participants received risankizumab 1200mg intravenously at Weeks 12, 16, and 20.
|
Period 2 Placebo/Risankizumab 1200mg IV
n=76 participants at risk
Participants who received placebo in Period 1 received 1200 mg risankizumab intravenously at Weeks 12, 16, and 20.
|
Period 2 Risankizumab Total
n=278 participants at risk
Total Period 2 participants randomized into the Risankizumab treatment arm
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
GASTROENTERITIS NOROVIRUS
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.3%
1/76 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Eye disorders
RETINAL DISORDER
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.3%
1/76 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.1%
2/186 • Number of events 3 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
COLITIS
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
8.1%
15/186 • Number of events 16 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.3%
5/373 • Number of events 7 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.54%
2/372 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.94%
7/745 • Number of events 9 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
GASTROINTESTINAL INFLAMMATION
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
GASTROINTESTINAL NECROSIS
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
ILEAL PERFORATION
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
ILEAL STENOSIS
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.54%
2/373 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
2/745 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
INTESTINAL ISCHAEMIA
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
1.1%
2/186 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/68 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.3%
1/76 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.1%
3/278 • Number of events 3 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
INTESTINAL STENOSIS
|
1.1%
2/186 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
2/745 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/68 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
2/745 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
SUBILEUS
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.3%
1/76 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
TERMINAL ILEITIS
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
VOMITING
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
General disorders
ASTHENIA
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
General disorders
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Hepatobiliary disorders
LIVER DISORDER
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Immune system disorders
FOOD ALLERGY
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
ABDOMINAL WALL ABSCESS
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
ABSCESS INTESTINAL
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
ANAL ABSCESS
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
GASTROENTERITIS
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
LEPTOSPIROSIS
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
PERITONITIS
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/68 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
PNEUMONIA
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
PULMONARY SEPSIS
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
TONSILLITIS
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
VULVAL CELLULITIS
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Injury, poisoning and procedural complications
FOREARM FRACTURE
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Investigations
BODY TEMPERATURE INCREASED
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Investigations
WEIGHT DECREASED
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Musculoskeletal and connective tissue disorders
ANKYLOSING SPONDYLITIS
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Musculoskeletal and connective tissue disorders
FIBROMYALGIA
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Musculoskeletal and connective tissue disorders
FISTULA
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Musculoskeletal and connective tissue disorders
SPONDYLITIS
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Nervous system disorders
DIZZINESS
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Nervous system disorders
SYNCOPE
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Psychiatric disorders
MENTAL DISORDER
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/68 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Psychiatric disorders
OBSESSIVE-COMPULSIVE DISORDER
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/745 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.54%
1/186 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Renal and urinary disorders
URETEROLITHIASIS
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.54%
2/373 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
2/745 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.36%
1/278 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/373 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/372 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/186 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.27%
1/373 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/372 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.13%
1/745 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/278 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
Other adverse events
| Measure |
Period 1 Placebo IV
n=186 participants at risk
Participants randomized to receive Placebo intravenous (IV) at Baseline, Weeks 4 and 8.
|
Period 1 Risankizumab 600mg IV
n=373 participants at risk
Participants randomized to receive risankizumab 600mg intravenous (IV) at Baseline, Weeks 4 and 8.
|
Period 1 Risankizumab 1200mg IV
n=372 participants at risk
Participants randomized to receive risankizumab 1200mg intravenous (IV) at Baseline, Weeks 4 and 8.
|
Period 1 Risankizumab Total
n=745 participants at risk
Total Period 1 participants randomized into the Risankizumab treatment arm
|
Period 2 Risankizumab 180mg SC
n=67 participants at risk
Participants randomized to receive risankizumab 180mg subcutaneously (SC) at Weeks 12 and 20.
|
Period 2 Risankizumab 360mg SC
n=68 participants at risk
Participants randomized to receive risankizumab 360mg subcutaneously (SC) at Weeks 12 and 20.
|
Period 2 Risankizumab 1200mg IV
n=67 participants at risk
Participants received risankizumab 1200mg intravenously at Weeks 12, 16, and 20.
|
Period 2 Placebo/Risankizumab 1200mg IV
n=76 participants at risk
Participants who received placebo in Period 1 received 1200 mg risankizumab intravenously at Weeks 12, 16, and 20.
|
Period 2 Risankizumab Total
n=278 participants at risk
Total Period 2 participants randomized into the Risankizumab treatment arm
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.7%
5/186 • Number of events 5 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
2.9%
11/373 • Number of events 11 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
2.4%
9/372 • Number of events 9 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
2.7%
20/745 • Number of events 20 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
2.9%
2/68 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
5.3%
4/76 • Number of events 4 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
2.5%
7/278 • Number of events 7 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
5.4%
10/186 • Number of events 10 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.3%
5/373 • Number of events 5 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.1%
4/372 • Number of events 4 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.2%
9/745 • Number of events 9 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
3.0%
2/67 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/68 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/76 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.1%
3/278 • Number of events 3 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Gastrointestinal disorders
NAUSEA
|
5.4%
10/186 • Number of events 10 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
4.3%
16/373 • Number of events 17 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
3.5%
13/372 • Number of events 13 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
3.9%
29/745 • Number of events 30 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/68 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
0.00%
0/67 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
3.9%
3/76 • Number of events 3 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.4%
4/278 • Number of events 4 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Infections and infestations
NASOPHARYNGITIS
|
2.7%
5/186 • Number of events 5 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
5.9%
22/373 • Number of events 24 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
5.9%
22/372 • Number of events 24 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
5.9%
44/745 • Number of events 48 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/68 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 1 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
2.6%
2/76 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.8%
5/278 • Number of events 5 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
|
Nervous system disorders
HEADACHE
|
4.3%
8/186 • Number of events 8 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
6.4%
24/373 • Number of events 25 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
5.4%
20/372 • Number of events 27 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
5.9%
44/745 • Number of events 52 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
1.5%
1/67 • Number of events 2 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
4.4%
3/68 • Number of events 3 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
3.0%
2/67 • Number of events 3 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
6.6%
5/76 • Number of events 5 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
4.0%
11/278 • Number of events 13 • Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
|
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