Trial Outcomes & Findings for A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis (NCT NCT03398148)
NCT ID: NCT03398148
Last Updated: 2025-01-16
Results Overview
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Sub-Study 1, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1558 participants
Primary outcome timeframe
Week 12
Results posted on
2025-01-16
Participant Flow
This study was comprised of 2 SubStudies, each had 2 Periods.
Participant milestones
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo
Participants who received placebo with inadequate response in Induction 1 receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
|
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo
Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Substudy 1 Period 1
STARTED
|
60
|
61
|
61
|
58
|
341
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 1
COMPLETED
|
53
|
55
|
58
|
57
|
306
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 1
NOT COMPLETED
|
7
|
6
|
3
|
1
|
35
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
72
|
70
|
36
|
37
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
65
|
57
|
34
|
35
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
7
|
13
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 2 Period 1
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
325
|
652
|
0
|
0
|
0
|
0
|
|
Substudy 2 Period 1
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
297
|
637
|
0
|
0
|
0
|
0
|
|
Substudy 2 Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
28
|
15
|
0
|
0
|
0
|
0
|
|
Substudy 2 Period 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
71
|
71
|
68
|
174
|
|
Substudy 2 Period 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
65
|
65
|
61
|
164
|
|
Substudy 2 Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
7
|
10
|
Reasons for withdrawal
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo
Participants who received placebo with inadequate response in Induction 1 receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
|
Substudy 2, Induction Period 1: Double-blind Placebo IV
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo
Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Substudy 1 Period 1
Adverse Event
|
5
|
2
|
2
|
0
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 1
WITHDREW CONSENT
|
1
|
2
|
0
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 1
Lack of Efficacy
|
1
|
1
|
1
|
0
|
20
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 1
Other
|
0
|
1
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 1
Enrolled but not Treated
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 2
WITHDREW CONSENT
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 2
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 2
COVID-19 LOGISTICAL RESTRICTIONS
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 2
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 Period 2
Enrolled but not Treated
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 2 Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
2
|
0
|
0
|
0
|
0
|
|
Substudy 2 Period 1
WITHDREW CONSENT
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
4
|
0
|
0
|
0
|
0
|
|
Substudy 2 Period 1
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
1
|
0
|
0
|
0
|
0
|
|
Substudy 2 Period 1
COVID-19 INFECTION
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Substudy 2 Period 1
COVID-19 LOGISTICAL RESTRICTIONS
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Substudy 2 Period 1
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
4
|
0
|
0
|
0
|
0
|
|
Substudy 2 Period 1
Enrolled but not Treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Substudy 2 Period 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
|
Substudy 2 Period 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Substudy 2 Period 2
WITHDREW CONSENT
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
2
|
1
|
|
Substudy 2 Period 2
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
3
|
4
|
|
Substudy 2 Period 2
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Substudy 2 Period 2
Enrolled but not Treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Population includes subjects who received at least one dose of study drug.
Baseline characteristics by cohort
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=60 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=61 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=61 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=58 Participants
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
n=340 Participants
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 2, Induction Period 1: Double-blind Placebo IV
n=325 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=650 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Total
n=1555 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Substudy 1
|
44.4 years
STANDARD_DEVIATION 14.09 • n=60 Participants • Population includes subjects who received at least one dose of study drug.
|
43.0 years
STANDARD_DEVIATION 14.90 • n=61 Participants • Population includes subjects who received at least one dose of study drug.
|
41.8 years
STANDARD_DEVIATION 13.80 • n=61 Participants • Population includes subjects who received at least one dose of study drug.
|
40.9 years
STANDARD_DEVIATION 13.73 • n=58 Participants • Population includes subjects who received at least one dose of study drug.
|
40.4 years
STANDARD_DEVIATION 14.17 • n=340 Participants • Population includes subjects who received at least one dose of study drug.
|
—
|
—
|
42.5 years
STANDARD_DEVIATION 14.12 • n=580 Participants • Population includes subjects who received at least one dose of study drug.
|
|
Age, Continuous
Substudy 2
|
—
|
—
|
—
|
—
|
—
|
42.8 years
STANDARD_DEVIATION 14.30 • n=325 Participants • Population includes subjects who received at least one dose of study drug.
|
41.8 years
STANDARD_DEVIATION 13.47 • n=650 Participants • Population includes subjects who received at least one dose of study drug.
|
42.1 years
STANDARD_DEVIATION 13.75 • n=975 Participants • Population includes subjects who received at least one dose of study drug.
|
|
Age, Customized
Age Group · 18 - <40
|
25 Participants
n=60 Participants
|
27 Participants
n=61 Participants
|
30 Participants
n=61 Participants
|
33 Participants
n=58 Participants
|
175 Participants
n=340 Participants
|
147 Participants
n=325 Participants
|
313 Participants
n=650 Participants
|
750 Participants
n=1555 Participants
|
|
Age, Customized
Age Group · 40 - <65
|
29 Participants
n=60 Participants
|
27 Participants
n=61 Participants
|
27 Participants
n=61 Participants
|
20 Participants
n=58 Participants
|
143 Participants
n=340 Participants
|
153 Participants
n=325 Participants
|
299 Participants
n=650 Participants
|
698 Participants
n=1555 Participants
|
|
Age, Customized
Age Group · ≥65
|
6 Participants
n=60 Participants
|
7 Participants
n=61 Participants
|
4 Participants
n=61 Participants
|
5 Participants
n=58 Participants
|
22 Participants
n=340 Participants
|
25 Participants
n=325 Participants
|
38 Participants
n=650 Participants
|
107 Participants
n=1555 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=60 Participants
|
21 Participants
n=61 Participants
|
26 Participants
n=61 Participants
|
27 Participants
n=58 Participants
|
145 Participants
n=340 Participants
|
124 Participants
n=325 Participants
|
265 Participants
n=650 Participants
|
632 Participants
n=1555 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=60 Participants
|
40 Participants
n=61 Participants
|
35 Participants
n=61 Participants
|
31 Participants
n=58 Participants
|
195 Participants
n=340 Participants
|
201 Participants
n=325 Participants
|
385 Participants
n=650 Participants
|
923 Participants
n=1555 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=60 Participants
|
2 Participants
n=61 Participants
|
6 Participants
n=61 Participants
|
1 Participants
n=58 Participants
|
21 Participants
n=340 Participants
|
20 Participants
n=325 Participants
|
44 Participants
n=650 Participants
|
97 Participants
n=1555 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=60 Participants
|
59 Participants
n=61 Participants
|
55 Participants
n=61 Participants
|
57 Participants
n=58 Participants
|
319 Participants
n=340 Participants
|
305 Participants
n=325 Participants
|
606 Participants
n=650 Participants
|
1458 Participants
n=1555 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=340 Participants
|
0 Participants
n=325 Participants
|
0 Participants
n=650 Participants
|
0 Participants
n=1555 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=340 Participants
|
0 Participants
n=325 Participants
|
1 Participants
n=650 Participants
|
1 Participants
n=1555 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=60 Participants
|
11 Participants
n=61 Participants
|
15 Participants
n=61 Participants
|
11 Participants
n=58 Participants
|
47 Participants
n=340 Participants
|
96 Participants
n=325 Participants
|
171 Participants
n=650 Participants
|
365 Participants
n=1555 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=340 Participants
|
0 Participants
n=325 Participants
|
0 Participants
n=650 Participants
|
0 Participants
n=1555 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=60 Participants
|
1 Participants
n=61 Participants
|
1 Participants
n=61 Participants
|
2 Participants
n=58 Participants
|
3 Participants
n=340 Participants
|
7 Participants
n=325 Participants
|
12 Participants
n=650 Participants
|
28 Participants
n=1555 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=60 Participants
|
49 Participants
n=61 Participants
|
45 Participants
n=61 Participants
|
45 Participants
n=58 Participants
|
290 Participants
n=340 Participants
|
218 Participants
n=325 Participants
|
461 Participants
n=650 Participants
|
1152 Participants
n=1555 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=340 Participants
|
4 Participants
n=325 Participants
|
5 Participants
n=650 Participants
|
9 Participants
n=1555 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=340 Participants
|
0 Participants
n=325 Participants
|
0 Participants
n=650 Participants
|
0 Participants
n=1555 Participants
|
|
Adapted Mayo Score
Substudy 1 - ITT1A Population
|
7.012 Adapted Mayo Score 0 - 9
STANDARD_DEVIATION 1.1645 • n=60 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
6.929 Adapted Mayo Score 0 - 9
STANDARD_DEVIATION 1.2240 • n=61 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
7.011 Adapted Mayo Score 0 - 9
STANDARD_DEVIATION 1.1288 • n=61 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
7.150 Adapted Mayo Score 0 - 9
STANDARD_DEVIATION 1.3908 • n=58 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
—
|
—
|
—
|
7.024 Adapted Mayo Score 0 - 9
STANDARD_DEVIATION 1.2240 • n=240 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
|
Adapted Mayo Score
Substudy 1 - ITT1B Population
|
—
|
—
|
—
|
—
|
7.179 Adapted Mayo Score 0 - 9
STANDARD_DEVIATION 1.2279 • n=340 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
—
|
—
|
7.179 Adapted Mayo Score 0 - 9
STANDARD_DEVIATION 1.2279 • n=340 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
|
Adapted Mayo Score
Substudy 2 - ITT2 Population
|
—
|
—
|
—
|
—
|
—
|
7.052 Adapted Mayo Score 0 - 9
STANDARD_DEVIATION 1.2800 • n=325 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
7.068 Adapted Mayo Score 0 - 9
STANDARD_DEVIATION 1.2173 • n=649 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
7.063 Adapted Mayo Score 0 - 9
STANDARD_DEVIATION 1.2380 • n=974 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
PRIMARY outcome
Timeframe: Week 12Population: ITT1A includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Substudy 1. ITT1B includes all the additional subjects who received at least one dose of risankizumab 1800 mg IV treatment group after 240 subjects were randomized during Induction Period 1 from Substudy 1.
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Sub-Study 1, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=60 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=61 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=61 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=58 Participants
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
n=340 Participants
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score
|
1 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
42 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: ITT2 population.
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Sub-Study 2, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1. Evidence of friability during endoscopy in subjects with otherwise "mild" endoscopic activity will confer an endoscopic subscore of 2.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=325 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=650 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score
|
6.2 percentage of participants
Interval 3.6 to 8.9
|
20.3 percentage of participants
Interval 17.2 to 23.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Includes ITT1A and ITT1B populations.
Endoscopic improvement is defined as endoscopy subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=60 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=61 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=61 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=58 Participants
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
n=340 Participants
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement
|
3 Participants
|
15 Participants
|
8 Participants
|
9 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: No data was collected.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \> 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: Includes ITT1A and ITT1B populations.
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo Score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response per Adapted Mayo Score was defined as decrease from baseline in Adapted Mayo Score ≥ 2 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=60 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=61 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=61 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=58 Participants
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
n=340 Participants
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score
|
12 Participants
|
26 Participants
|
28 Participants
|
31 Participants
|
157 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Includes ITT1A and ITT1B populations.
Clinical response per Partial Adapted Mayo Score (without endoscopy). The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) The overall Partial Mayo Score ranges from 0 to 6 with higher scores representing more severe disease. Clinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score \>= 1 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=60 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=61 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=61 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=58 Participants
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
n=340 Participants
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score
|
15 Participants
|
20 Participants
|
28 Participants
|
22 Participants
|
148 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Includes ITT1A and ITT1B populations.
Endoscopic remission was defined as endoscopy subscore of 0.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=60 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=61 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=61 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=58 Participants
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
n=340 Participants
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission
|
0 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Through Week 12Population: Includes ITT1A and ITT1B populations.
Participants with an event that results in admission to the hospital.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=60 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=61 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=61 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=58 Participants
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
n=340 Participants
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 1: Percentage of Participants With Hospitalization
|
5 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Includes ITT1A and ITT1B populations.
Mucosal healing defined as endoscopic and histologic remission. Mucosal healing is defined as an endoscopic score of 0 and Geboes score \< 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=60 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=61 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=61 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=58 Participants
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
n=340 Participants
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR)
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline Through Week 12Population: Includes ITT1A and ITT1B participants with data available for analysis.
The US-SQ is a patient questionnaire to assess severity of Ulcerative Colitis (UC) related gastrointestinal symptoms (e.g., frequent bowel movements, abdominal pain, cramping) and non-gastrointestinal symptoms (e.g., joint pain and sleep difficulties). It consists of 17 questions and each question is answered on a scale from can be answered on a scale from 1 (Not at all/ never) to 5 (Very much/Always) with overall symptom score range from 17 to 85. A lower score indicates lower UC severity.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=50 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=52 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=56 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=53 Participants
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
n=286 Participants
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ)
|
-7.4 units on a scale
Standard Error 1.53
|
-13.8 units on a scale
Standard Error 1.50
|
-15.6 units on a scale
Standard Error 1.46
|
-15.1 units on a scale
Standard Error 1.51
|
-17.1 units on a scale
Standard Error 0.58
|
SECONDARY outcome
Timeframe: Baseline Through Week 12Population: Includes ITT1A and ITT1B participants with data available for analysis.
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease. 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 |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=51 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=55 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=59 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=54 Participants
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
n=305 Participants
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
|
20.1 units on a scale
Standard Error 4.67
|
37.4 units on a scale
Standard Error 4.56
|
40.3 units on a scale
Standard Error 4.38
|
40.0 units on a scale
Standard Error 4.55
|
49.5 units on a scale
Standard Error 1.86
|
SECONDARY outcome
Timeframe: Baseline Through Week 12Population: Includes ITT1A and ITT1B participants with data available for analysis.
The SF-36 (Version 2) is a self-administered, health-related survey that measures the impact of disease on overall quality of life during the past 4 weeks. SF-36 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental \[MCS\] and physical \[PCS\]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=51 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=54 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=59 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=54 Participants
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
n=298 Participants
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Physical Component
|
3.904 units on a scale
Standard Error 0.8907
|
5.112 units on a scale
Standard Error 0.8751
|
6.350 units on a scale
Standard Error 0.8341
|
6.296 units on a scale
Standard Error 0.8675
|
7.719 units on a scale
Standard Error 0.3929
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: Includes ITT1A and ITT1B participants with data available for analysis.
The SF-36 (Version 2) is a self-administered, health-related survey that measures the impact of disease on overall quality of life during the past 4 weeks. SF-36 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental \[MCS\] and physical \[PCS\]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=51 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=54 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=59 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=54 Participants
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
n=298 Participants
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Mental Component
|
3.094 unites on a scale
Standard Error 1.2533
|
6.756 unites on a scale
Standard Error 1.2319
|
7.284 unites on a scale
Standard Error 1.1739
|
5.442 unites on a scale
Standard Error 1.2185
|
7.777 unites on a scale
Standard Error 0.4777
|
SECONDARY outcome
Timeframe: Baseline Through Week 12Population: Includes ITT1A and ITT1B participants with data available for analysis.
The FACIT-Fatigue Scale is a validated self-administered 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. 0 = not at all 1. = a little bit 2. = somewhat 3. = quite a bit 4. = very much 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 |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=51 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=54 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=59 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=54 Participants
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
n=298 Participants
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
|
3.7 units on a scale
Standard Error 1.37
|
7.6 units on a scale
Standard Error 1.35
|
9.0 units on a scale
Standard Error 1.29
|
8.3 units on a scale
Standard Error 1.33
|
10.7 units on a scale
Standard Error 0.54
|
SECONDARY outcome
Timeframe: Through Week 12Population: Includes ITT1A and ITT1B populations.
Participants who underwent surgery related to UC.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=60 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=61 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=61 Participants
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=58 Participants
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
n=340 Participants
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-Related Surgeries
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo Score ranges from 0 to 9 where higher scores represent more severe disease. Clinical Response is defined as a decrease from baseline in the Adapted Mayo Score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=325 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=650 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score
|
35.7 percentage of participants
Interval 30.5 to 40.9
|
64.3 percentage of participants
Interval 60.6 to 67.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Endoscopic Improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=325 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=650 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement
|
12.1 percentage of participants
Interval 8.5 to 15.6
|
36.5 percentage of participants
Interval 32.8 to 40.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Histologic-Endoscopic Mucosal Improvement is defined as an endoscopic subscore of 0 or 1 without evidence of friability and a Geboes score ≤ 3.1. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=325 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=650 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI)
|
7.7 percentage of participants
Interval 4.8 to 10.6
|
24.5 percentage of participants
Interval 21.2 to 27.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Endoscopic remission per endoscopy subscore. Endoscopic Remission: endoscopic subscore = 0.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=325 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=650 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission
|
3.4 percentage of participants
Interval 1.4 to 5.4
|
10.6 percentage of participants
Interval 8.2 to 13.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Clinical response per Partial Adapted Mayo Score (without endoscopy). The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) The overall Partial Mayo Score ranges from 0 to 6 with higher scores representing more severe disease. Clinical Response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo Score ≥ 1 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=325 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=650 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score at Week 4
|
30.5 percentage of participants
Interval 25.5 to 35.5
|
52.2 percentage of participants
Interval 48.3 to 56.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Percentage of participants who reported no bowel urgency. Bowel urgency was assessed by participants in a subject diary completed once a day.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=325 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=650 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency
|
27.7 percentage of participants
Interval 22.8 to 32.6
|
44.1 percentage of participants
Interval 40.3 to 47.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Percentage of participants who reported no abdominal pain. Abdominal pain was assessed by participants in a subject diary completed once a day.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=325 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=650 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain
|
26.5 percentage of participants
Interval 21.7 to 31.3
|
35.8 percentage of participants
Interval 32.1 to 39.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Mucosal healing defined as endoscopic and histologic remission. Mucosal healing is defined as an endoscopic score of 0 and Geboes score \< 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=325 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=650 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR): Endoscopy Subscore of 0 and Geboes Score < 2.0) at Week 12
|
0.6 percentage of participants
Interval 0.0 to 1.5
|
6.3 percentage of participants
Interval 4.4 to 8.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Includes ITT2 participants with data available for analysis.
The FACIT-Fatigue Scale is a validated self-administered 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. 0 = not at all 1. = a little bit 2. = somewhat 3. = quite a bit 4. = very much 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 |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=308 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=614 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
|
3.3 units on a scale
Interval 2.12 to 4.5
|
7.9 units on a scale
Interval 7.03 to 8.69
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Includes ITT2 participants with data available for analysis.
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease. 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 |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=310 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=619 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
|
24.3 units on a scale
Interval 20.19 to 28.46
|
42.6 units on a scale
Interval 39.72 to 45.57
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Through Week 12Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Participants with an UC-related event that results in admission to the hospital.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=325 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=650 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Occurrence of UC-related Hospitalizations
|
5.5 percentage of participants
Interval 3.1 to 8.0
|
0.8 percentage of participants
Interval 0.1 to 1.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Percentage of participants who reported no nocturnal bowel movements.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=325 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=650 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements
|
43.1 percentage of participants
Interval 37.7 to 48.5
|
67.3 percentage of participants
Interval 63.7 to 70.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2.
Percentage of participants who reported no tenesmus.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=325 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=650 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Percentage of Participants Achieving No Tenesmus
|
30.2 percentage of participants
Interval 25.2 to 35.1
|
48.7 percentage of participants
Interval 44.9 to 52.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Includes ITT2 participants with data available for analysis.
Change in number of fecal incontinence episodes per week.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=288 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=602 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Change in Number of Fecal Incontinence Episodes Per Week
|
-2.213 Fecal Incontinence Episodes/ week
Interval -2.8526 to -1.5726
|
-3.839 Fecal Incontinence Episodes/ week
Interval -4.2687 to -3.4099
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Includes ITT2 participants with data available for analysis.
Change from baseline in number of days per week with sleep interrupted due to UC symptoms.
Outcome measures
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=288 Participants
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=602 Participants
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
|---|---|---|---|---|---|
|
Sub-Study 2: Change in Number of Days Per Week With Sleep Interrupted Due to UC Symptoms
|
-1.505 days
Interval -1.7969 to -1.2122
|
-2.485 days
Interval -2.6872 to -2.2831
|
—
|
—
|
—
|
Adverse Events
Substudy 1, Induction Period 1: Double-blind Placebo IV
Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Substudy 1, Induction Period 1: Openlabel Risankizumab 1800mg IV
Serious events: 25 serious events
Other events: 76 other events
Deaths: 0 deaths
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC
Serious events: 6 serious events
Other events: 4 other events
Deaths: 0 deaths
Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Substudy 2, Induction Period 1: Double-blind Placebo IV
Serious events: 34 serious events
Other events: 64 other events
Deaths: 0 deaths
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
Serious events: 17 serious events
Other events: 101 other events
Deaths: 1 deaths
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=59 participants at risk
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
1 participant assigned to Placebo IV was dosed with Risankizumab 600 mg IV and is counted in that arm.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=62 participants at risk
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
1 participant assigned to Placebo IV was dosed with Risankizumab 600 mg IV and is counted in this arm.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=61 participants at risk
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=58 participants at risk
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Openlabel Risankizumab 1800mg IV
n=341 participants at risk
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo
n=36 participants at risk
Participants who received placebo with inadequate response in Induction 1 receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
1 subject was dosed differently in period S1P1 (assigned to Pbo IV but dosed with Risa 600mg IV). This subject was classified into Risa 1800mg IV vs IV PbO based on the treatment received in S1P1.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV
n=37 participants at risk
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
1 subject was dosed differently in period S1P1 (assigned to Pbo IV but dosed with Risa 600mg IV). This subject was classified into Risa 1800mg IV vs IV PbO based on the treatment received in S1P1.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC
n=71 participants at risk
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
1 participant assigned to Risankizumab 180mg SC was dosed with Risankizumab 360mg SC and is counted in that arm.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC
n=71 participants at risk
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
1 participant assigned to Risankizumab 180mg SC was dosed with Risankizumab 360mg SC and is counted in this arm.
|
Substudy 2, Induction Period 1: Double-blind Placebo IV
n=324 participants at risk
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
1 participant assigned to Placebo IV was dosed with Risankizumab 1200mg IV and is counted in that arm.
|
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=653 participants at risk
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
1 participant assigned to Placebo IV was dosed with Risankizumab 1200mg IV and is counted in this arm.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo
n=174 participants at risk
Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV
n=68 participants at risk
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC
n=71 participants at risk
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC
n=71 participants at risk
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
3.3%
2/61 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.62%
2/324 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
2/653 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Blood and lymphatic system disorders
BLOOD LOSS ANAEMIA
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.7%
1/58 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Endocrine disorders
BASEDOW'S DISEASE
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Eye disorders
CATARACT
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.29%
1/341 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.62%
2/324 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Gastrointestinal disorders
ANAL PROLAPSE
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.29%
1/341 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.6%
1/62 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.7%
1/58 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
5.1%
3/59 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.6%
1/62 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
4.7%
16/341 • Number of events 17 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.8%
1/36 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
4.2%
3/71 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.8%
2/71 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
4.9%
16/324 • Number of events 18 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.46%
3/653 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.57%
1/174 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Gastrointestinal disorders
ENTERITIS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.15%
1/653 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.57%
1/174 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
General disorders
PYREXIA
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.6%
1/62 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.15%
1/653 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.59%
2/341 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.7%
1/58 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
COVID-19
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.15%
1/653 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.5%
1/68 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.15%
1/653 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.57%
1/174 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.57%
1/174 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.6%
1/62 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.29%
1/341 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.7%
1/58 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
ENDOCARDITIS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
ENTERITIS INFECTIOUS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.8%
1/36 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
LARGE INTESTINE INFECTION
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.6%
1/61 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
LUNG ABSCESS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.8%
1/36 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
PAROTID ABSCESS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
PHARYNGEAL ABSCESS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.15%
1/653 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
PNEUMONIA HAEMOPHILUS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.6%
1/62 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
PNEUMONIA MYCOPLASMAL
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.29%
1/341 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.29%
1/341 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
RECTAL ABSCESS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.29%
1/341 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
SALMONELLOSIS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.7%
1/37 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.7%
1/58 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Injury, poisoning and procedural complications
FOREARM FRACTURE
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.7%
1/58 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.7%
1/58 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.57%
1/174 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Injury, poisoning and procedural complications
SKELETAL INJURY
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.15%
1/653 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.15%
1/653 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.15%
1/653 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.29%
1/341 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
1.7%
1/59 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.8%
1/36 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.15%
1/653 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLORECTAL ADENOMA
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.15%
1/653 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PITUITARY TUMOUR BENIGN
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
1.7%
1/59 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Nervous system disorders
CEREBRAL MASS EFFECT
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.15%
1/653 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Psychiatric disorders
ADJUSTMENT DISORDER
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Psychiatric disorders
GENERALISED ANXIETY DISORDER
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.15%
1/653 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.29%
1/341 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.6%
1/61 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.29%
1/341 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Reproductive system and breast disorders
UTERINE PROLAPSE
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.29%
1/341 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.29%
1/341 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
2/653 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA NODOSUM
|
1.7%
1/59 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Skin and subcutaneous tissue disorders
PEMPHIGOID
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.8%
1/36 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Vascular disorders
ARTERIAL OCCLUSIVE DISEASE
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.6%
1/62 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.29%
1/341 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.15%
1/653 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Vascular disorders
PERIPHERAL ARTERY OCCLUSION
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
Other adverse events
| Measure |
Substudy 1, Induction Period 1: Double-blind Placebo IV
n=59 participants at risk
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
1 participant assigned to Placebo IV was dosed with Risankizumab 600 mg IV and is counted in that arm.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
n=62 participants at risk
Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
1 participant assigned to Placebo IV was dosed with Risankizumab 600 mg IV and is counted in this arm.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=61 participants at risk
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
n=58 participants at risk
Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 1: Openlabel Risankizumab 1800mg IV
n=341 participants at risk
Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo
n=36 participants at risk
Participants who received placebo with inadequate response in Induction 1 receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
1 subject was dosed differently in period S1P1 (assigned to Pbo IV but dosed with Risa 600mg IV). This subject was classified into Risa 1800mg IV vs IV PbO based on the treatment received in S1P1.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV
n=37 participants at risk
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
1 subject was dosed differently in period S1P1 (assigned to Pbo IV but dosed with Risa 600mg IV). This subject was classified into Risa 1800mg IV vs IV PbO based on the treatment received in S1P1.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC
n=71 participants at risk
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
1 participant assigned to Risankizumab 180mg SC was dosed with Risankizumab 360mg SC and is counted in that arm.
|
Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC
n=71 participants at risk
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
1 participant assigned to Risankizumab 180mg SC was dosed with Risankizumab 360mg SC and is counted in this arm.
|
Substudy 2, Induction Period 1: Double-blind Placebo IV
n=324 participants at risk
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
1 participant assigned to Placebo IV was dosed with Risankizumab 1200mg IV and is counted in that arm.
|
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
n=653 participants at risk
Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
1 participant assigned to Placebo IV was dosed with Risankizumab 1200mg IV and is counted in this arm.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo
n=174 participants at risk
Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV
n=68 participants at risk
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC
n=71 participants at risk
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
|
Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC
n=71 participants at risk
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
3.4%
2/59 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
3.3%
2/61 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.7%
1/58 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
3.5%
12/341 • Number of events 12 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.7%
1/37 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
5.9%
19/324 • Number of events 21 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
3.2%
21/653 • Number of events 21 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.9%
5/174 • Number of events 5 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.5%
1/68 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.8%
2/71 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
8.5%
6/71 • Number of events 6 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
8.5%
5/59 • Number of events 6 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.6%
1/62 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
4.9%
3/61 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.7%
1/58 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
3.5%
12/341 • Number of events 12 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.8%
1/36 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.7%
1/37 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
4.2%
3/71 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
5.2%
17/324 • Number of events 17 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.5%
10/653 • Number of events 10 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.7%
3/174 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.5%
1/68 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
4.2%
3/71 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
5.1%
3/59 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/341 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.8%
1/36 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.77%
5/653 • Number of events 6 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
6.5%
4/62 • Number of events 4 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.6%
1/61 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.29%
1/341 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
2/653 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.57%
1/174 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.5%
1/68 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
COVID-19
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.29%
1/341 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/36 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
5.9%
19/324 • Number of events 19 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
4.6%
30/653 • Number of events 30 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
5.7%
10/174 • Number of events 10 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
5.9%
4/68 • Number of events 4 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
5.6%
4/71 • Number of events 4 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
8.5%
6/71 • Number of events 6 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.8%
4/59 • Number of events 5 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
8.1%
5/62 • Number of events 5 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
4.9%
3/61 • Number of events 5 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
8.6%
5/58 • Number of events 6 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
7.0%
24/341 • Number of events 26 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
5.6%
2/36 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
10.8%
4/37 • Number of events 5 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
8.5%
6/71 • Number of events 6 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.5%
8/324 • Number of events 9 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.8%
18/653 • Number of events 18 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.7%
3/174 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
5.6%
4/71 • Number of events 4 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
PHARYNGITIS
|
1.7%
1/59 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.6%
1/62 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.88%
3/341 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
5.6%
2/36 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/324 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/653 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.57%
1/174 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/62 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.6%
1/61 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.7%
1/58 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.88%
3/341 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
5.6%
2/36 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.8%
2/71 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.31%
1/324 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.15%
1/653 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Nervous system disorders
HEADACHE
|
5.1%
3/59 • Number of events 4 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
3.2%
2/62 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
4.9%
3/61 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
6.9%
4/58 • Number of events 5 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
6.5%
22/341 • Number of events 25 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
5.6%
2/36 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.8%
2/71 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
7.0%
5/71 • Number of events 5 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.2%
7/324 • Number of events 8 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.9%
19/653 • Number of events 25 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.7%
3/174 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
2.9%
2/68 • Number of events 4 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
8.5%
6/71 • Number of events 6 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/59 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
3.2%
2/62 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/61 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/58 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.2%
4/341 • Number of events 4 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
5.6%
2/36 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/37 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
1.4%
1/71 • Number of events 1 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.62%
2/324 • Number of events 2 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.46%
3/653 • Number of events 3 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/174 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/68 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
|
0.00%
0/71 • In S1P1, median time on follow-up was 86, 86, 85, 87, & 87 days(d) for S1P1 DB-PboIV, S1P1 DB-Risankizumab(Risa) 600mgIV, S1P1 DB-Risa 1200mgIV, S1P1 DB-Risa 1800mgIV, and S1P1 OL-Risa 1800mgIV; respectively. In S1P2, median time on follow-up was 87, 106, 93 and 93 d for arms S1P2 DB -Risa 1800mgIVPbo, S1P2 DB-Risa1800mgIV, S1P2 DB-Risa 180mgSC, and S1P2 DB-Risa 360mgSC; respectively. In S2P1, median time on follow-up was 87 and 89d for arms S2P1 DB-PboIV, S2P1 DB Risa1200mgIV, respectively.
In S2P2, median time on follow-up was 143.5, 159, 197and 193d for arms, S2P2 DB-Risa1200mgIVPbo, S2P2 DB-Risa 1200mgIV, S2P2 DB-Risa 180mgSC, and S2P2 DB-Risa 360mgSC; respectively. Safety Events were categorized according to arm subjects were dosed; N=3; 1 subject dosed differently in period S1P1. This subject was assigned into Risa 1800mg IV PbO group in S1P2 (Participant Flow) based on randomization in S1P1, but classified into Risa 1800mg IV S1P2 based on the treatment received in S1P1.
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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