Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment (NCT NCT03104413)
NCT ID: NCT03104413
Last Updated: 2022-06-14
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
618 participants
Primary outcome timeframe
Week 12
Results posted on
2022-06-14
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 618 subjects were enrolled and 605 were included in the intent-to-treat (ITT) population; 569 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 |
Placebo (Induction Period 1)
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab Dose 180mg (Induction Period 2)
Participants randomized to receive risankizumab 180mg by subcutaneous(SC) injection at Weeks 12 and 20.
risankizumab SC: risankizumab administered by subcutaneous (SC) injection.
|
Risankizumab 360mg (Induction Period 2)
Participants randomized to receive risankizumab 360mg by subcutaneous injection at Weeks 12 and 20.
risankizumab SC: risankizumab administered by subcutaneous (SC) injection
|
Risankizumab 1200mg (Induction Period 2)
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Weeks 12, 16 and 20.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Placebo/Risankizumab 1200mg (Induction Period 2)
Participants who received placebo in Induction Period 1 received 1200 mg risankizumab by intravenous infusion at Weeks 12, 16, and 20.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|
|
Induction Period 1
STARTED
|
207
|
206
|
205
|
0
|
0
|
0
|
0
|
|
Induction Period 1
COMPLETED
|
186
|
202
|
199
|
0
|
0
|
0
|
0
|
|
Induction Period 1
NOT COMPLETED
|
21
|
4
|
6
|
0
|
0
|
0
|
0
|
|
Induction Period 2
STARTED
|
0
|
0
|
0
|
41
|
42
|
42
|
86
|
|
Induction Period 2
COMPLETED
|
0
|
0
|
0
|
39
|
39
|
38
|
76
|
|
Induction Period 2
NOT COMPLETED
|
0
|
0
|
0
|
2
|
3
|
4
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Baseline characteristics by cohort
| Measure |
Placebo (Induction Period 1)
n=207 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=206 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=205 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Total
n=618 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
193 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
582 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Age, Continuous
|
39.4 years
STANDARD_DEVIATION 13.28 • n=5 Participants
|
40.4 years
STANDARD_DEVIATION 13.54 • n=7 Participants
|
39.6 years
STANDARD_DEVIATION 12.85 • n=5 Participants
|
39.8 years
STANDARD_DEVIATION 13.22 • n=4 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
309 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
309 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
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
176 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
547 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during 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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
|
19.8 percentage of participants
Interval 14.1 to 25.5
|
42.0 percentage of participants
Interval 34.9 to 49.0
|
40.3 percentage of participants
Interval 33.4 to 47.3
|
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Endoscopic Response
|
11.2 percentage of participants
Interval 6.7 to 15.8
|
28.8 percentage of participants
Interval 22.4 to 35.3
|
34.2 percentage of participants
Interval 27.4 to 40.9
|
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Clinical Remission
|
11.2 percentage of participants
Interval 6.7 to 15.8
|
28.8 percentage of participants
Interval 22.4 to 35.3
|
34.2 percentage of participants
Interval 27.4 to 40.9
|
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Endoscopic Response
|
19.3 percentage of participants
Interval 13.6 to 24.9
|
34.6 percentage of participants
Interval 27.8 to 41.3
|
39.8 percentage of participants
Interval 32.8 to 46.7
|
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Clinical Remission
|
19.3 percentage of participants
Interval 13.6 to 24.9
|
34.6 percentage of participants
Interval 27.8 to 41.3
|
39.8 percentage of participants
Interval 32.8 to 46.7
|
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
|
20.9 percentage of participants
Interval 15.0 to 26.7
|
36.6 percentage of participants
Interval 29.8 to 43.5
|
32.5 percentage of participants
Interval 25.8 to 39.1
|
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.
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
|
30.0 percentage of participants
Interval 23.4 to 36.6
|
59.5 percentage of participants
Interval 52.5 to 66.5
|
60.7 percentage of participants
Interval 53.8 to 67.7
|
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 (Induction Period 1)
n=144 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=168 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=172 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
|
7.7 units on a scale
Standard Error 0.87
|
10.5 units on a scale
Standard Error 0.81
|
10.8 units on a scale
Standard Error 0.81
|
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
|
11.2 percentage of participants
Interval 6.7 to 15.8
|
20.9 percentage of participants
Interval 15.2 to 26.7
|
19.4 percentage of participants
Interval 13.8 to 25.0
|
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response
|
5.3 percentage of participants
Interval 2.1 to 8.6
|
20.5 percentage of participants
Interval 14.7 to 26.2
|
23.0 percentage of participants
Interval 17.1 to 29.0
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the 12-Week Induction Period 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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Stool Frequency (SF) Remission
|
28.3 percentage of participants
Interval 21.9 to 34.8
|
46.1 percentage of participants
Interval 39.9 to 53.1
|
48.7 percentage of participants
Interval 41.6 to 55.8
|
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.
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Abdominal Pain (AP) Remission
|
36.4 percentage of participants
Interval 29.5 to 43.3
|
58.1 percentage of participants
Interval 51.1 to 65.1
|
59.2 percentage of participants
Interval 52.2 to 66.1
|
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.
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Endoscopic Remission
|
4.3 percentage of participants
Interval 1.4 to 7.2
|
19.4 percentage of participants
Interval 13.8 to 25.1
|
20.4 percentage of participants
Interval 14.7 to 26.1
|
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Enhanced Clinical Response
|
31.6 percentage of participants
Interval 24.9 to 38.2
|
45.0 percentage of participants
Interval 38.0 to 52.1
|
38.7 percentage of participants
Interval 31.8 to 45.7
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the 12-Week Induction Period 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 (Induction Period 1)
n=186 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=190 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=189 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Ulcer-Free Endoscopy
|
4.3 percentage of participants
Interval 1.4 to 7.2
|
13.8 percentage of participants
Interval 8.9 to 18.7
|
15.4 percentage of participants
Interval 10.2 to 20.5
|
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.
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Enhanced Clinical Response
|
39.1 percentage of participants
Interval 32.1 to 46.1
|
61.8 percentage of participants
Interval 54.9 to 68.7
|
59.2 percentage of participants
Interval 52.2 to 66.1
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the 12-Week Induction Period 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 (Induction Period 1)
n=97 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=100 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=97 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
|
23.7 percentage of participants
Interval 15.2 to 32.2
|
29.5 percentage of participants
Interval 20.5 to 38.5
|
37.1 percentage of participants
Interval 27.5 to 46.7
|
SECONDARY outcome
Timeframe: Up to 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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants With CD-Related Hospitalization
|
11.2 percentage of participants
Interval 6.7 to 15.8
|
3.1 percentage of participants
Interval 0.7 to 5.6
|
2.1 percentage of participants
Interval 0.1 to 4.1
|
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.
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Outcome measures
| Measure |
Placebo (Induction Period 1)
n=15 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=14 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=16 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
|
13.3 percentage of participants
Interval 0.0 to 30.5
|
7.1 percentage of participants
Interval 0.0 to 20.6
|
43.8 percentage of participants
Interval 19.4 to 68.1
|
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.
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
|
19.8 percentage of participants
Interval 14.1 to 25.5
|
42 percentage of participants
Interval 34.9 to 49.0
|
40.3 percentage of participants
Interval 33.4 to 47.3
|
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 response is defined as reduction of CDAI ≥ 100 points from baseline.
Outcome measures
| Measure |
Placebo (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
|
20.9 percentage of participants
Interval 15.0 to 26.7
|
36.6 percentage of participants
Interval 29.8 to 43.5
|
32.5 percentage of participants
Interval 25.8 to 39.1
|
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Clinical Remission
|
8 percentage of participants
Interval 4.1 to 11.9
|
17.3 percentage of participants
Interval 11.9 to 22.6
|
18.3 percentage of participants
Interval 12.8 to 23.8
|
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.
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
|
30.0 percentage of participants
Interval 23.4 to 36.6
|
59.5 percentage of participants
Interval 52.5 to 66.5
|
60.7 percentage of participants
Interval 53.8 to 67.7
|
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 (Induction Period 1)
n=144 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=168 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=172 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
|
7.7 units on a scale
Standard Error 0.87
|
10.5 units on a scale
Standard Error 0.81
|
10.8 units on a scale
Standard Error 0.81
|
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 (Induction Period 1)
n=144 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=168 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=172 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
|
27.2 units on a scale
Interval 21.8 to 32.6
|
39.6 units on a scale
Interval 34.5 to 44.7
|
42.2 units on a scale
Interval 37.1 to 47.3
|
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 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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response
|
7 percentage of participants
Interval 3.3 to 10.6
|
21 percentage of participants
Interval 15.2 to 26.8
|
24.1 percentage of participants
Interval 18.0 to 30.1
|
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.
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US:: Percentage of Participants With Endoscopic Remission
|
4.3 percentage of participants
Interval 1.4 to 7.2
|
19.4 percentage of participants
Interval 13.8 to 25.1
|
20.4 percentage of participants
Interval 14.7 to 26.1
|
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
|
31.6 percentage of participants
Interval 24.9 to 38.2
|
45 percentage of participants
Interval 38.0 to 52.1
|
38.7 percentage of participants
Interval 31.8 to 45.7
|
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 (Induction Period 1)
n=186 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=190 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=189 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy
|
4.3 percentage of participants
Interval 1.4 to 7.2
|
13.8 percentage of participants
Interval 8.9 to 18.7
|
15.4 percentage of participants
Interval 10.2 to 20.5
|
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.
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
|
39.1 percentage of participants
Interval 32.1 to 46.1
|
61.8 percentage of participants
Interval 54.9 to 68.7
|
59.2 percentage of participants
Interval 52.2 to 66.1
|
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.
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 (Induction Period 1)
n=97 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=100 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=97 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
|
23.7 percentage of participants
Interval 15.2 to 32.2
|
29.5 percentage of participants
Interval 20.5 to 38.5
|
37.1 percentage of participants
Interval 27.5 to 46.7
|
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 (Induction Period 1)
n=187 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=191 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants With CD-Related Hospitalization
|
11.2 percentage of participants
Interval 6.7 to 15.8
|
3.1 percentage of participants
Interval 0.7 to 5.6
|
2.1 percentage of participants
Interval 0.1 to 4.1
|
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.
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Outcome measures
| Measure |
Placebo (Induction Period 1)
n=15 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=14 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=16 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
|
13.3 percentage of participants
Interval 0.0 to 30.5
|
7.1 percentage of participants
Interval 0.0 to 20.6
|
43.8 percentage of participants
Interval 19.4 to 68.1
|
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.
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 (Induction Period 1)
n=68 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=73 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=86 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment
|
-12.253 units on a scale
Standard Error 3.3683
|
-19.576 units on a scale
Standard Error 3.2747
|
-21.013 units on a scale
Standard Error 3.0074
|
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 (Induction Period 1)
n=142 Participants
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 600mg (Induction Period 1)
n=167 Participants
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
Risankizumab 1200mg (Induction Period 1)
n=172 Participants
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
risankizumab IV: risankizumab administered as intravenous (IV) infusion.
|
|---|---|---|---|
|
Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score
|
5.237 units on a scale
Standard Error 0.6166
|
7.458 units on a scale
Standard Error 0.5767
|
7.951 units on a scale
Standard Error 0.5749
|
Adverse Events
Placebo (Induction Period 1)
Serious events: 26 serious events
Other events: 51 other events
Deaths: 0 deaths
Risankizumab 600mg (Induction Period 1)
Serious events: 10 serious events
Other events: 32 other events
Deaths: 0 deaths
Risankizumab 1200mg (Induction Period 1)
Serious events: 9 serious events
Other events: 32 other events
Deaths: 2 deaths
Period 1 Risankizumab Total
Serious events: 19 serious events
Other events: 64 other events
Deaths: 2 deaths
Risankizumab Dose 180mg (Induction Period 2)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Risankizumab 360mg (Induction Period 2)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Risankizumab 1200mg (Induction Period 2)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 1 deaths
Placebo/Risankizumab 1200mg (Induction Period 2)
Serious events: 9 serious events
Other events: 12 other events
Deaths: 0 deaths
Period 2 Risankizumab Total
Serious events: 16 serious events
Other events: 28 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo (Induction Period 1)
n=207 participants at risk
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
|
Risankizumab 600mg (Induction Period 1)
n=206 participants at risk
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
|
Risankizumab 1200mg (Induction Period 1)
n=205 participants at risk
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
|
Period 1 Risankizumab Total
n=411 participants at risk
Total Period 1 participants randomized into the Risankizumab treatment arm
|
Risankizumab Dose 180mg (Induction Period 2)
n=41 participants at risk
Participants randomized to receive risankizumab 180mg by subcutaneous (SC) injection at Weeks 12 and 20.
|
Risankizumab 360mg (Induction Period 2)
n=42 participants at risk
Participants randomized to receive risankizumab 360mg by subcutaneous injection at Weeks 12 and 20.
|
Risankizumab 1200mg (Induction Period 2)
n=42 participants at risk
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Weeks 12, 16 and 20.
|
Placebo/Risankizumab 1200mg (Induction Period 2)
n=86 participants at risk
Participants who received placebo in Induction Period 1 received 1200 mg risankizumab by intravenous infusion at Weeks 12, 16, and 20.
|
Period 2 Risankizumab Total
n=211 participants at risk
Total Period 2 participants randomized into the Risankizumab treatment arm
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.97%
2/206 • Number of events 2 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.98%
2/205 • Number of events 2 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.97%
4/411 • Number of events 4 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.2%
1/86 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Blood and lymphatic system disorders
BONE MARROW FAILURE
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Blood and lymphatic system disorders
MYELOSUPPRESSION
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/206 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
4.9%
2/41 • Number of events 2 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.95%
2/211 • Number of events 2 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/206 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
ANAL SPHINCTER ATONY
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
ANAL STENOSIS
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.2%
1/86 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
ANORECTAL DISORDER
|
0.48%
1/207 • Number of events 2 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
9.7%
20/207 • Number of events 22 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/206 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/205 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
2/411 • Number of events 2 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
4.8%
2/42 • Number of events 2 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.3%
2/86 • Number of events 2 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.9%
4/211 • Number of events 4 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
DYSBIOSIS
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/206 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
ILEAL STENOSIS
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.2%
1/86 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/206 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
1/42 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
JEJUNAL STENOSIS
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.2%
1/86 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
NAUSEA
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
1/41 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.97%
2/207 • Number of events 2 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/206 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.2%
1/86 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
General disorders
PYREXIA
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/205 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
1/41 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Hepatobiliary disorders
BILE DUCT STENOSIS
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/206 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.2%
1/86 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.2%
1/86 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Infections and infestations
CELLULITIS OF MALE EXTERNAL GENITAL ORGAN
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.2%
1/86 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Infections and infestations
GASTROENTERITIS ESCHERICHIA COLI
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/205 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Infections and infestations
PNEUMONIA STAPHYLOCOCCAL
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.2%
1/86 • Number of events 2 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 2 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Infections and infestations
SEPSIS
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/205 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
1/42 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Infections and infestations
VIRAL MYOCARDITIS
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Infections and infestations
VIRAL PHARYNGITIS
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/206 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC LEAK
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
1/42 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.2%
1/86 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/206 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF LUNG
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/205 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
1/42 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.2%
1/86 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.47%
1/211 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.48%
1/207 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/205 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/411 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/205 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/205 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/205 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Surgical and medical procedures
INCISIONAL HERNIA REPAIR
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/205 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Vascular disorders
LERICHE SYNDROME
|
0.00%
0/207 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/206 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.49%
1/205 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.24%
1/411 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/211 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
Other adverse events
| Measure |
Placebo (Induction Period 1)
n=207 participants at risk
Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.
|
Risankizumab 600mg (Induction Period 1)
n=206 participants at risk
Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.
|
Risankizumab 1200mg (Induction Period 1)
n=205 participants at risk
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.
|
Period 1 Risankizumab Total
n=411 participants at risk
Total Period 1 participants randomized into the Risankizumab treatment arm
|
Risankizumab Dose 180mg (Induction Period 2)
n=41 participants at risk
Participants randomized to receive risankizumab 180mg by subcutaneous (SC) injection at Weeks 12 and 20.
|
Risankizumab 360mg (Induction Period 2)
n=42 participants at risk
Participants randomized to receive risankizumab 360mg by subcutaneous injection at Weeks 12 and 20.
|
Risankizumab 1200mg (Induction Period 2)
n=42 participants at risk
Participants randomized to receive risankizumab 1200mg by intravenous infusion at Weeks 12, 16 and 20.
|
Placebo/Risankizumab 1200mg (Induction Period 2)
n=86 participants at risk
Participants who received placebo in Induction Period 1 received 1200 mg risankizumab by intravenous infusion at Weeks 12, 16, and 20.
|
Period 2 Risankizumab Total
n=211 participants at risk
Total Period 2 participants randomized into the Risankizumab treatment arm
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.3%
11/207 • Number of events 12 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.5%
3/206 • Number of events 3 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.0%
4/205 • Number of events 4 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.7%
7/411 • Number of events 7 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.3%
2/86 • Number of events 3 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.95%
2/211 • Number of events 3 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
6.3%
13/207 • Number of events 13 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
3.4%
7/206 • Number of events 7 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.5%
3/205 • Number of events 3 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
10/411 • Number of events 10 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
1/41 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
4.8%
2/42 • Number of events 2 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.2%
1/86 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.9%
4/211 • Number of events 4 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Gastrointestinal disorders
NAUSEA
|
4.8%
10/207 • Number of events 10 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
5/206 • Number of events 6 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.5%
3/205 • Number of events 4 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.9%
8/411 • Number of events 10 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/41 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
1/42 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
7.1%
3/42 • Number of events 3 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/86 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
1.9%
4/211 • Number of events 4 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.3%
11/207 • Number of events 12 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
3.9%
8/206 • Number of events 8 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
3.9%
8/205 • Number of events 8 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
3.9%
16/411 • Number of events 16 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
1/41 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
0.00%
0/42 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
4.8%
2/42 • Number of events 2 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.3%
2/86 • Number of events 2 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
5/211 • Number of events 5 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
3.9%
8/207 • Number of events 8 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
3.9%
8/206 • Number of events 8 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
4.4%
9/205 • Number of events 10 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
4.1%
17/411 • Number of events 18 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
4.9%
2/41 • Number of events 3 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
1/42 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
1/42 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
5.8%
5/86 • Number of events 5 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
4.3%
9/211 • Number of events 10 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
|
Nervous system disorders
HEADACHE
|
5.3%
11/207 • Number of events 12 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
5.3%
11/206 • Number of events 14 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
4.9%
10/205 • Number of events 11 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
5.1%
21/411 • Number of events 25 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
1/41 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
2.4%
1/42 • Number of events 1 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
7.1%
3/42 • Number of events 3 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
4.7%
4/86 • Number of events 4 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
4.3%
9/211 • Number of events 9 • From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
|
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