Trial Outcomes & Findings for Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease (NCT NCT02914561)
NCT ID: NCT02914561
Last Updated: 2023-12-18
Results Overview
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical remission was defined as a CDAI of \< 150 points.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1372 participants
Primary outcome timeframe
Week 10
Results posted on
2023-12-18
Participant Flow
Participants with diagnosis of moderately to severely Active Crohn's disease (CD) were enrolled in the study. Participants who were biologic-naïve or biologic-experienced were enrolled in Cohort A and participants who were biologic-experienced were enrolled in Cohort B, respectively.
Participants who met protocol eligibility criteria were assigned to the respective Cohort and subsequently randomized in a blinded fashion in a 1:1:1 ratio to 1 of 3 treatments: filgotinib 200 milligram (mg), filgotinib 100 mg and placebo.
Participant milestones
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 mg with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
|
Filgotinib 200 mg to Placebo (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
|
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
|
Filgotinib 100 mg to Placebo (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
|
Placebo to Placebo (Maintenance Study)
Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Study (Day 1 to Week 10)
STARTED
|
223
|
245
|
239
|
204
|
230
|
231
|
0
|
0
|
0
|
0
|
0
|
|
Induction Study (Day 1 to Week 10)
Treated
|
222
|
245
|
237
|
202
|
228
|
229
|
0
|
0
|
0
|
0
|
0
|
|
Induction Study (Day 1 to Week 10)
COMPLETED
|
204
|
213
|
212
|
177
|
183
|
192
|
0
|
0
|
0
|
0
|
0
|
|
Induction Study (Day 1 to Week 10)
NOT COMPLETED
|
19
|
32
|
27
|
27
|
47
|
39
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Study (Weeks 11 to 58)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
118
|
56
|
105
|
56
|
146
|
|
Maintenance Study (Weeks 11 to 58)
Treated
|
0
|
0
|
0
|
0
|
0
|
0
|
118
|
56
|
104
|
55
|
145
|
|
Maintenance Study (Weeks 11 to 58)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
64
|
21
|
45
|
26
|
74
|
|
Maintenance Study (Weeks 11 to 58)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
54
|
35
|
60
|
30
|
72
|
Reasons for withdrawal
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 mg with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
|
Filgotinib 200 mg to Placebo (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
|
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
|
Filgotinib 100 mg to Placebo (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
|
Placebo to Placebo (Maintenance Study)
Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Study (Day 1 to Week 10)
Adverse Event
|
15
|
14
|
14
|
24
|
31
|
19
|
0
|
0
|
0
|
0
|
0
|
|
Induction Study (Day 1 to Week 10)
Withdrawal by Subject
|
1
|
9
|
6
|
0
|
7
|
12
|
0
|
0
|
0
|
0
|
0
|
|
Induction Study (Day 1 to Week 10)
Protocol Violation
|
0
|
4
|
1
|
1
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Induction Study (Day 1 to Week 10)
Physician Decision
|
1
|
5
|
2
|
0
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Induction Study (Day 1 to Week 10)
Non-Compliance with Study Drug
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Induction Study (Day 1 to Week 10)
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Study (Day 1 to Week 10)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Study (Day 1 to Week 10)
Randomized but not treated
|
1
|
0
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Study (Weeks 11 to 58)
Protocol-Specified Disease Worsening
|
0
|
0
|
0
|
0
|
0
|
0
|
31
|
32
|
40
|
25
|
43
|
|
Maintenance Study (Weeks 11 to 58)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
2
|
11
|
2
|
12
|
|
Maintenance Study (Weeks 11 to 58)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
1
|
2
|
1
|
9
|
|
Maintenance Study (Weeks 11 to 58)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
2
|
0
|
4
|
|
Maintenance Study (Weeks 11 to 58)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
1
|
3
|
|
Maintenance Study (Weeks 11 to 58)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
1
|
0
|
0
|
|
Maintenance Study (Weeks 11 to 58)
Non-Compliance with Study Drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Maintenance Study (Weeks 11 to 58)
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance Study (Weeks 11 to 58)
Randomized but not treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
Baseline Characteristics
Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=223 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=245 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=239 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=204 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
n=230 Participants
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
n=231 Participants
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Total
n=1372 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Region of Enrollment
Germany
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
19 participants
n=4 Participants
|
18 participants
n=21 Participants
|
19 participants
n=8 Participants
|
83 participants
n=8 Participants
|
|
Region of Enrollment
Singapore
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
4 participants
n=8 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
213 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
220 Participants
n=21 Participants
|
227 Participants
n=8 Participants
|
1313 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
59 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
129 Participants
n=21 Participants
|
116 Participants
n=8 Participants
|
706 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
115 Participants
n=8 Participants
|
666 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
214 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
217 Participants
n=21 Participants
|
220 Participants
n=8 Participants
|
1313 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
45 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
221 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
166 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
182 Participants
n=21 Participants
|
178 Participants
n=8 Participants
|
1048 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
54 Participants
n=8 Participants
|
|
Region of Enrollment
Hong Kong
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
4 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
41 participants
n=7 Participants
|
45 participants
n=5 Participants
|
51 participants
n=4 Participants
|
84 participants
n=21 Participants
|
60 participants
n=8 Participants
|
303 participants
n=8 Participants
|
|
Region of Enrollment
Czechia
|
2 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
5 participants
n=8 Participants
|
28 participants
n=8 Participants
|
|
Region of Enrollment
Malaysia
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
8 participants
n=8 Participants
|
|
Region of Enrollment
Portugal
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
9 participants
n=8 Participants
|
|
Region of Enrollment
Iceland
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
|
Region of Enrollment
Russia
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
2 participants
n=8 Participants
|
24 participants
n=8 Participants
|
|
Region of Enrollment
Greece
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=8 Participants
|
3 participants
n=8 Participants
|
|
Region of Enrollment
Netherlands
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
7 participants
n=21 Participants
|
9 participants
n=8 Participants
|
36 participants
n=8 Participants
|
|
Region of Enrollment
South Korea
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
5 participants
n=8 Participants
|
18 participants
n=8 Participants
|
|
Region of Enrollment
Sweden
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
2 participants
n=8 Participants
|
|
Region of Enrollment
Ireland
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
7 participants
n=8 Participants
|
|
Region of Enrollment
Poland
|
35 participants
n=5 Participants
|
25 participants
n=7 Participants
|
34 participants
n=5 Participants
|
12 participants
n=4 Participants
|
7 participants
n=21 Participants
|
12 participants
n=8 Participants
|
125 participants
n=8 Participants
|
|
Region of Enrollment
Slovakia
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
4 participants
n=8 Participants
|
15 participants
n=8 Participants
|
|
Region of Enrollment
France
|
19 participants
n=5 Participants
|
15 participants
n=7 Participants
|
16 participants
n=5 Participants
|
28 participants
n=4 Participants
|
21 participants
n=21 Participants
|
31 participants
n=8 Participants
|
130 participants
n=8 Participants
|
|
Region of Enrollment
Serbia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
3 participants
n=8 Participants
|
|
Region of Enrollment
Croatia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
4 participants
n=8 Participants
|
|
Region of Enrollment
Romania
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=8 Participants
|
9 participants
n=8 Participants
|
|
Region of Enrollment
Hungary
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
16 participants
n=8 Participants
|
|
Region of Enrollment
Sri Lanka
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
12 participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
8 participants
n=5 Participants
|
12 participants
n=4 Participants
|
10 participants
n=21 Participants
|
13 participants
n=8 Participants
|
61 participants
n=8 Participants
|
|
Region of Enrollment
Ukraine
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
20 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
54 participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
7 participants
n=21 Participants
|
6 participants
n=8 Participants
|
33 participants
n=8 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
4 participants
n=8 Participants
|
13 participants
n=8 Participants
|
|
Region of Enrollment
India
|
23 participants
n=5 Participants
|
30 participants
n=7 Participants
|
20 participants
n=5 Participants
|
7 participants
n=4 Participants
|
6 participants
n=21 Participants
|
5 participants
n=8 Participants
|
91 participants
n=8 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
8 participants
n=21 Participants
|
3 participants
n=8 Participants
|
27 participants
n=8 Participants
|
|
Region of Enrollment
New Zealand
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
2 participants
n=8 Participants
|
11 participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
7 participants
n=4 Participants
|
4 participants
n=21 Participants
|
4 participants
n=8 Participants
|
37 participants
n=8 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=5 Participants
|
11 participants
n=7 Participants
|
7 participants
n=5 Participants
|
15 participants
n=4 Participants
|
12 participants
n=21 Participants
|
11 participants
n=8 Participants
|
62 participants
n=8 Participants
|
|
Region of Enrollment
Norway
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
4 participants
n=8 Participants
|
|
Region of Enrollment
Taiwan
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=8 Participants
|
10 participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=5 Participants
|
8 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
6 participants
n=21 Participants
|
5 participants
n=8 Participants
|
32 participants
n=8 Participants
|
|
Region of Enrollment
South Africa
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
9 participants
n=8 Participants
|
|
Region of Enrollment
Georgia
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
4 participants
n=8 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=5 Participants
|
9 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
3 participants
n=21 Participants
|
7 participants
n=8 Participants
|
29 participants
n=8 Participants
|
|
Region of Enrollment
Australia
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
4 participants
n=4 Participants
|
9 participants
n=21 Participants
|
11 participants
n=8 Participants
|
49 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 10Population: The Full Analysis Set (FAS) for each Induction Study (Cohorts A and B) included all randomized participants who took at least 1 dose of study drug in the corresponding Induction Study.
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical remission was defined as a CDAI of \< 150 points.
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=222 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=245 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=237 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=202 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
n=228 Participants
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
n=229 Participants
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
|
32.9 percentage of participants
Interval 26.5 to 39.3
|
25.7 percentage of participants
Interval 20.0 to 31.4
|
19.8 percentage of participants
Interval 14.5 to 25.1
|
26.7 percentage of participants
Interval 20.4 to 33.1
|
16.7 percentage of participants
Interval 11.6 to 21.7
|
14.8 percentage of participants
Interval 10.0 to 19.7
|
PRIMARY outcome
Timeframe: Week 10Population: FAS for induction study was analyzed.
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=222 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=245 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=237 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=202 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
n=228 Participants
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
n=229 Participants
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10
|
23.9 percentage of participants
Interval 18.0 to 29.7
|
20.8 percentage of participants
Interval 15.5 to 26.1
|
18.1 percentage of participants
Interval 13.0 to 23.3
|
11.9 percentage of participants
Interval 7.2 to 16.6
|
13.6 percentage of participants
Interval 8.9 to 18.3
|
11.4 percentage of participants
Interval 7.0 to 15.7
|
PRIMARY outcome
Timeframe: Week 58Population: The FAS for the Maintenance Study included all participants randomized to either the filgotinib 200 mg or filgotinib 100 mg treatment groups in the Induction Studies who were re-randomized in the Maintenance Study and took at least 1 dose of study drug in the Maintenance Study and achieved clinical remission by PRO2 or endoscopic response at Week 10.
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical remission was defined as a CDAI of \< 150 points.
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=112 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=98 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=53 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=53 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58
|
42.9 percentage of participants
Interval 33.2 to 52.5
|
23.5 percentage of participants
Interval 14.6 to 32.4
|
28.3 percentage of participants
Interval 15.2 to 41.4
|
22.6 percentage of participants
Interval 10.4 to 34.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 58Population: The FAS for the Maintenance Study was analyzed.
The SES-CD assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=112 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=98 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=53 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=53 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58
|
30.4 percentage of participants
Interval 21.4 to 39.3
|
18.4 percentage of participants
Interval 10.2 to 26.5
|
9.4 percentage of participants
Interval 0.6 to 18.2
|
13.2 percentage of participants
Interval 3.1 to 23.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10Population: FAS for induction study was analyzed.
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=222 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=245 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=237 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=202 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
n=228 Participants
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
n=229 Participants
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10
|
32.9 percentage of participants
Interval 26.5 to 39.3
|
30.6 percentage of participants
Interval 24.6 to 36.6
|
25.7 percentage of participants
Interval 20.0 to 31.5
|
29.7 percentage of participants
Interval 23.2 to 36.3
|
18.9 percentage of participants
Interval 13.6 to 24.2
|
17.9 percentage of participants
Interval 12.7 to 23.1
|
SECONDARY outcome
Timeframe: Week 10Population: FAS for induction study was analyzed.
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score \< 150 points.
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=222 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=245 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=237 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=202 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
n=228 Participants
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
n=229 Participants
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10
|
52.3 percentage of participants
Interval 45.5 to 59.0
|
46.1 percentage of participants
Interval 39.7 to 52.6
|
39.7 percentage of participants
Interval 33.2 to 46.1
|
38.6 percentage of participants
Interval 31.7 to 45.6
|
35.5 percentage of participants
Interval 29.1 to 42.0
|
27.5 percentage of participants
Interval 21.5 to 33.5
|
SECONDARY outcome
Timeframe: Week 58Population: The FAS for the Maintenance Study was analyzed.
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=112 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=98 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=53 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=53 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58
|
43.8 percentage of participants
Interval 34.1 to 53.4
|
29.6 percentage of participants
Interval 20.0 to 39.1
|
26.4 percentage of participants
Interval 13.6 to 39.2
|
24.5 percentage of participants
Interval 12.0 to 37.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 58Population: The FAS for the Maintenance Study was analyzed.
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score \< 150 points.
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=112 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=98 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=53 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=53 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58
|
45.5 percentage of participants
Interval 35.9 to 55.2
|
33.7 percentage of participants
Interval 23.8 to 43.5
|
34.0 percentage of participants
Interval 20.3 to 47.7
|
30.2 percentage of participants
Interval 16.9 to 43.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 10 and 58Population: The FAS for the Maintenance Study was analyzed.
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Sustained Clinical Remission by CDAI: CDAI \<150 combined at both Week 10 and Week 58.
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=112 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=98 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=53 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=53 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58
|
38.4 percentage of participants
Interval 28.9 to 47.8
|
19.4 percentage of participants
Interval 11.1 to 27.7
|
22.6 percentage of participants
Interval 10.4 to 34.9
|
20.8 percentage of participants
Interval 8.9 to 32.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 58Population: The FAS for the Maintenance Study with available data was analyzed.
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. 6-Month Corticosteroid-Free Clinical remission by CDAI: CDAI \<150 with no corticosteroid use for indication of Crohn's disease for at least 6 months prior to Week 58.
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=50 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=41 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=25 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=25 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58
|
34.0 percentage of participants
Interval 19.9 to 48.1
|
4.9 percentage of participants
Interval 0.0 to 12.7
|
20.0 percentage of participants
Interval 2.3 to 37.7
|
12.0 percentage of participants
Interval 0.0 to 26.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 10 and 58Population: The FAS for the Maintenance Study was analyzed.
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Sustained Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 combined at both Week 10 and Week 58.
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=112 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=98 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=53 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=53 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58
|
41.1 percentage of participants
Interval 31.5 to 50.6
|
25.5 percentage of participants
Interval 16.4 to 34.7
|
20.8 percentage of participants
Interval 8.9 to 32.6
|
24.5 percentage of participants
Interval 12.0 to 37.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 58Population: The FAS for the Maintenance Study with available data was analyzed.
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. 6-month Corticosteroid-Free Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 with no corticosteroid use for at least 6 months prior to Week 58.
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=50 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=41 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=25 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=25 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58
|
32.0 percentage of participants
Interval 18.1 to 45.9
|
7.3 percentage of participants
Interval 0.0 to 16.5
|
20.0 percentage of participants
Interval 2.3 to 37.7
|
12.0 percentage of participants
Interval 0.0 to 26.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4: 0.5, 1, 2, and 3 hours (hrs) post dosePopulation: Pharmacokinetic (PK) Analysis Set (included all randomized participants who took at least 1 dose of filgotinib and had at least 1 non-missing concentration value for filgotinib and/or its metabolite GS-829845 reported by the PK laboratory) for Induction study was analyzed.
Plasma concentrations of filgotinib \[nanogram/milliliters (ng/mL)\].
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=177 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=181 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=141 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=168 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4
|
1170 ng/mL
Standard Deviation 1270
|
611 ng/mL
Standard Deviation 634
|
1140 ng/mL
Standard Deviation 1070
|
604 ng/mL
Standard Deviation 634
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10: PredosePopulation: PK Analysis Set for Induction study was analyzed.
Plasma concentrations of filgotinib (ng/mL).
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=183 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=180 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=136 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=135 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10
|
46.8 ng/mL
Standard Deviation 180
|
21.3 ng/mL
Standard Deviation 79.5
|
47.9 ng/mL
Standard Deviation 215
|
40.8 ng/mL
Standard Deviation 139
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 26: At any timepointPopulation: PK Analysis Set for Maintenance study was analyzed
Plasma concentrations of filgotinib (ng/mL).
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=77 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=63 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26
|
284 ng/mL
Standard Deviation 623
|
58.5 ng/mL
Standard Deviation 150
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 58: Pre-dosePopulation: PK Analysis Set for Maintenance study was analyzed
Plasma concentrations of filgotinib (ng/mL).
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=34 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=27 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58
|
75.8 ng/mL
Standard Deviation 238
|
16.9 ng/mL
Standard Deviation 55.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4: 0.5, 1, 2, and 3 hrs post dosePopulation: PK Analysis Set for Induction study was analyzed.
Plasma concentrations of GS-829845 (ng/mL).
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=177 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=181 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=141 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=168 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4
|
3100 ng/mL
Standard Deviation 1530
|
1800 ng/mL
Standard Deviation 936
|
3140 ng/mL
Standard Deviation 1450
|
1870 ng/mL
Standard Deviation 776
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10: PredosePopulation: PK Analysis Set for Induction study was analyzed.
Plasma concentrations of GS-829845 (ng/mL).
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=183 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=180 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=136 Participants
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=135 Participants
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 10
|
2550 ng/mL
Standard Deviation 1390
|
1290 ng/mL
Standard Deviation 801
|
2640 ng/mL
Standard Deviation 1470
|
1480 ng/mL
Standard Deviation 917
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 26: At any timepointPopulation: PK Analysis Set for Maintenance study was analyzed
Plasma concentrations of GS-829845 (ng/mL).
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=77 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=63 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26
|
3090 ng/mL
Standard Deviation 1500
|
1460 ng/mL
Standard Deviation 814
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 58: Pre-dosePopulation: PK Analysis Set for Maintenance study was analyzed
Plasma concentrations of GS-829845 (ng/mL).
Outcome measures
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=34 Participants
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=27 Participants
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
|---|---|---|---|---|---|---|
|
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58
|
2430 ng/mL
Standard Deviation 1430
|
1220 ng/mL
Standard Deviation 551
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort A: Filgotinib 200 mg (Induction Study)
Serious events: 18 serious events
Other events: 87 other events
Deaths: 0 deaths
Cohort A: Filgotinib 100 mg (Induction Study)
Serious events: 16 serious events
Other events: 90 other events
Deaths: 0 deaths
Cohort A: Placebo (Induction Study)
Serious events: 15 serious events
Other events: 90 other events
Deaths: 0 deaths
Cohort B: Filgotinib 200 mg (Induction Study)
Serious events: 19 serious events
Other events: 106 other events
Deaths: 0 deaths
Cohort B: Filgotinib 100 mg (Induction Study)
Serious events: 36 serious events
Other events: 107 other events
Deaths: 0 deaths
Cohort B: Placebo (Induction Study)
Serious events: 26 serious events
Other events: 109 other events
Deaths: 0 deaths
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
Serious events: 13 serious events
Other events: 59 other events
Deaths: 0 deaths
Filgotinib 200 mg to Placebo (Maintenance Study)
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Serious events: 14 serious events
Other events: 59 other events
Deaths: 0 deaths
Filgotinib 100 mg to Placebo (Maintenance Study)
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo to Placebo (Maintenance Study)
Serious events: 14 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=222 participants at risk
Biologic naïve and biologic experienced participants received filgotinib 200 mg with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=245 participants at risk
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=237 participants at risk
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks..
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=202 participants at risk
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks
|
Cohort B: Filgotinib 100 mg (Induction Study)
n=228 participants at risk
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
n=229 participants at risk
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
n=118 participants at risk
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
|
Filgotinib 200 mg to Placebo (Maintenance Study)
n=56 participants at risk
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
|
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
n=104 participants at risk
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
|
Filgotinib 100 mg to Placebo (Maintenance Study)
n=55 participants at risk
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
|
Placebo to Placebo (Maintenance Study)
n=145 participants at risk
Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Cardiac disorders
Autoimmune myocarditis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Cardiac disorders
Palpitations
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Nervous system disorders
Sciatica
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/55 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Eye disorders
Central serous chorioretinopathy
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Eye disorders
Corneal scar
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.41%
1/245 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/56 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Crohn's disease
|
3.2%
7/222 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
3.7%
9/245 • Number of events 9 • From first dose up to Week 62
Safety Analysis Set
|
3.0%
7/237 • Number of events 8 • From first dose up to Week 62
Safety Analysis Set
|
4.5%
9/202 • Number of events 9 • From first dose up to Week 62
Safety Analysis Set
|
4.4%
10/228 • Number of events 10 • From first dose up to Week 62
Safety Analysis Set
|
4.4%
10/229 • Number of events 10 • From first dose up to Week 62
Safety Analysis Set
|
2.5%
3/118 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/56 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
6.7%
7/104 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/55 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
2.8%
4/145 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrointestinal wall thickening
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.41%
1/245 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.82%
2/245 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/56 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.41%
1/245 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.82%
2/245 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.41%
1/245 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Rectal ulcer hemorrhage
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
1.4%
2/145 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/56 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Renal and urinary disorders
Calculus urinary
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.41%
1/245 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Renal and urinary disorders
Renal colic
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthritis enteropathic
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Peripheral spondyloarthritis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Endocrine disorders
Primary adrenal insufficiency
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Abdominal abscess
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Appendicitis perforated
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Anal abscess
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/228 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
1.7%
2/118 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Bacteremia
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Bartholinitis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.41%
1/245 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
COVID-19
|
0.90%
2/222 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Cellulitis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Escherichia bacteremia
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Large intestine infection
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Oral candidiasis
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Oral herpes
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Pneumonia
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.41%
1/245 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Pyelonephritis
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/55 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Sepsis
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Systemic candida
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 10 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
General disorders
Asthenia
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
General disorders
Pyrexia
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.84%
2/237 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
Other adverse events
| Measure |
Cohort A: Filgotinib 200 mg (Induction Study)
n=222 participants at risk
Biologic naïve and biologic experienced participants received filgotinib 200 mg with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Filgotinib 100 mg (Induction Study)
n=245 participants at risk
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort A: Placebo (Induction Study)
n=237 participants at risk
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks..
|
Cohort B: Filgotinib 200 mg (Induction Study)
n=202 participants at risk
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks
|
Cohort B: Filgotinib 100 mg (Induction Study)
n=228 participants at risk
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
|
Cohort B: Placebo (Induction Study)
n=229 participants at risk
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
|
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
n=118 participants at risk
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
|
Filgotinib 200 mg to Placebo (Maintenance Study)
n=56 participants at risk
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
|
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
n=104 participants at risk
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
|
Filgotinib 100 mg to Placebo (Maintenance Study)
n=55 participants at risk
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
|
Placebo to Placebo (Maintenance Study)
n=145 participants at risk
Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
4.5%
10/222 • Number of events 11 • From first dose up to Week 62
Safety Analysis Set
|
4.1%
10/245 • Number of events 10 • From first dose up to Week 62
Safety Analysis Set
|
2.5%
6/237 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
5.4%
11/202 • Number of events 17 • From first dose up to Week 62
Safety Analysis Set
|
3.5%
8/228 • Number of events 8 • From first dose up to Week 62
Safety Analysis Set
|
4.4%
10/229 • Number of events 12 • From first dose up to Week 62
Safety Analysis Set
|
5.1%
6/118 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
7.1%
4/56 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
2.9%
3/104 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/55 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.4%
2/145 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
|
General disorders
Oedema peripheral
|
0.90%
2/222 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.41%
1/245 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
2.2%
5/228 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
1.7%
2/118 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
General disorders
Fatigue
|
3.2%
7/222 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
2.0%
5/245 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
1.7%
4/237 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
1.5%
3/202 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
2.6%
6/228 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
2.2%
5/229 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
1.7%
2/118 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
1.9%
2/104 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
1.4%
2/145 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
3/222 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
3.3%
8/245 • Number of events 8 • From first dose up to Week 62
Safety Analysis Set
|
3.0%
7/237 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
3.0%
6/202 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
3.5%
8/228 • Number of events 8 • From first dose up to Week 62
Safety Analysis Set
|
0.87%
2/229 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
2.5%
3/118 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
5.4%
3/56 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
2.9%
3/104 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/55 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
2.8%
4/145 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
|
Investigations
Weight decreased
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
1.2%
3/245 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
2.0%
4/202 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
2.2%
5/228 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
1.7%
4/229 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/56 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
2.9%
3/104 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
2.3%
5/222 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
1.6%
4/245 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
1.7%
4/237 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
3.5%
7/202 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/229 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/56 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/55 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
5.9%
13/222 • Number of events 14 • From first dose up to Week 62
Safety Analysis Set
|
6.5%
16/245 • Number of events 17 • From first dose up to Week 62
Safety Analysis Set
|
5.1%
12/237 • Number of events 12 • From first dose up to Week 62
Safety Analysis Set
|
8.4%
17/202 • Number of events 19 • From first dose up to Week 62
Safety Analysis Set
|
6.1%
14/228 • Number of events 15 • From first dose up to Week 62
Safety Analysis Set
|
6.6%
15/229 • Number of events 18 • From first dose up to Week 62
Safety Analysis Set
|
3.4%
4/118 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/56 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
3.8%
4/104 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/55 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
6.9%
10/145 • Number of events 13 • From first dose up to Week 62
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.90%
2/222 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.82%
2/245 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.7%
4/237 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
2.5%
5/202 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.87%
2/229 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/56 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
2.1%
3/145 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
3/222 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
2.0%
4/202 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/228 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/229 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
1.7%
2/118 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/56 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
4.8%
5/104 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/55 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.4%
2/145 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
3/222 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/237 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
1.5%
3/202 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/228 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/229 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
5.4%
3/56 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
7.2%
16/222 • Number of events 16 • From first dose up to Week 62
Safety Analysis Set
|
2.4%
6/245 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
3.4%
8/237 • Number of events 8 • From first dose up to Week 62
Safety Analysis Set
|
5.0%
10/202 • Number of events 14 • From first dose up to Week 62
Safety Analysis Set
|
3.5%
8/228 • Number of events 12 • From first dose up to Week 62
Safety Analysis Set
|
6.6%
15/229 • Number of events 15 • From first dose up to Week 62
Safety Analysis Set
|
6.8%
8/118 • Number of events 8 • From first dose up to Week 62
Safety Analysis Set
|
10.7%
6/56 • Number of events 9 • From first dose up to Week 62
Safety Analysis Set
|
8.7%
9/104 • Number of events 9 • From first dose up to Week 62
Safety Analysis Set
|
5.5%
3/55 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
6.2%
9/145 • Number of events 11 • From first dose up to Week 62
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.8%
4/222 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
2.0%
5/245 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
1.7%
4/237 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.99%
2/202 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
4/228 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/229 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
1.9%
2/104 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
1.4%
2/145 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Crohn's disease
|
2.3%
5/222 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
6.1%
15/245 • Number of events 15 • From first dose up to Week 62
Safety Analysis Set
|
6.8%
16/237 • Number of events 16 • From first dose up to Week 62
Safety Analysis Set
|
4.0%
8/202 • Number of events 8 • From first dose up to Week 62
Safety Analysis Set
|
6.1%
14/228 • Number of events 16 • From first dose up to Week 62
Safety Analysis Set
|
7.9%
18/229 • Number of events 18 • From first dose up to Week 62
Safety Analysis Set
|
12.7%
15/118 • Number of events 16 • From first dose up to Week 62
Safety Analysis Set
|
17.9%
10/56 • Number of events 10 • From first dose up to Week 62
Safety Analysis Set
|
21.2%
22/104 • Number of events 24 • From first dose up to Week 62
Safety Analysis Set
|
27.3%
15/55 • Number of events 15 • From first dose up to Week 62
Safety Analysis Set
|
17.9%
26/145 • Number of events 26 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.90%
2/222 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.82%
2/245 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/237 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.88%
2/228 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/229 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
1.9%
2/104 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/55 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
5/222 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
0.82%
2/245 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.84%
2/237 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
2.0%
4/202 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
3.1%
7/228 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
2.2%
5/229 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
5.4%
3/56 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
3.8%
4/104 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
2.8%
4/145 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.90%
2/222 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.41%
1/245 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
2.0%
4/202 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
1.7%
4/229 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
2.1%
3/145 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Flatulence
|
1.4%
3/222 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
1.6%
4/245 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.84%
2/237 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
3.5%
7/202 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
5.4%
3/56 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
5.0%
11/222 • Number of events 11 • From first dose up to Week 62
Safety Analysis Set
|
4.1%
10/245 • Number of events 10 • From first dose up to Week 62
Safety Analysis Set
|
4.6%
11/237 • Number of events 11 • From first dose up to Week 62
Safety Analysis Set
|
9.9%
20/202 • Number of events 21 • From first dose up to Week 62
Safety Analysis Set
|
4.4%
10/228 • Number of events 12 • From first dose up to Week 62
Safety Analysis Set
|
7.9%
18/229 • Number of events 19 • From first dose up to Week 62
Safety Analysis Set
|
5.1%
6/118 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
5.4%
3/56 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
2.9%
3/104 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/55 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
2.8%
4/145 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
4/222 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.82%
2/245 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.84%
2/237 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.5%
3/202 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
2.6%
6/228 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
2.6%
6/229 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
4.2%
5/118 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/56 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/55 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
1.4%
2/145 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.82%
2/245 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
2.0%
4/202 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.88%
2/228 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/229 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
2.9%
3/104 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/55 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
5/222 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
0.82%
2/245 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.84%
2/237 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
2.0%
4/202 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/56 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.45%
1/222 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.82%
2/245 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.87%
2/229 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
2.9%
3/104 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
5/222 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
4.5%
11/245 • Number of events 12 • From first dose up to Week 62
Safety Analysis Set
|
2.5%
6/237 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
3.5%
7/202 • Number of events 10 • From first dose up to Week 62
Safety Analysis Set
|
6.1%
14/228 • Number of events 14 • From first dose up to Week 62
Safety Analysis Set
|
3.9%
9/229 • Number of events 15 • From first dose up to Week 62
Safety Analysis Set
|
2.5%
3/118 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/56 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
9.6%
10/104 • Number of events 12 • From first dose up to Week 62
Safety Analysis Set
|
7.3%
4/55 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
6.9%
10/145 • Number of events 11 • From first dose up to Week 62
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
0.90%
2/222 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
2.9%
7/245 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
3.0%
7/237 • Number of events 8 • From first dose up to Week 62
Safety Analysis Set
|
2.5%
5/202 • Number of events 11 • From first dose up to Week 62
Safety Analysis Set
|
2.6%
6/228 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
3.9%
9/229 • Number of events 9 • From first dose up to Week 62
Safety Analysis Set
|
4.2%
5/118 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/56 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
4.8%
5/104 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/55 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
2.1%
3/145 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.84%
2/237 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.87%
2/229 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
1.9%
2/104 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
2.8%
4/145 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.41%
1/245 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.84%
2/237 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.50%
1/202 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/228 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.87%
2/229 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
2.5%
3/118 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/145 • From first dose up to Week 62
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
2.9%
7/245 • Number of events 7 • From first dose up to Week 62
Safety Analysis Set
|
0.84%
2/237 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
2.5%
5/202 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
2.2%
5/228 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
0.87%
2/229 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.7%
2/118 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/55 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
2.1%
3/145 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
0.45%
1/222 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.99%
2/202 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/228 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
3.4%
4/118 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/56 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
3.4%
5/145 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.4%
3/222 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.41%
1/245 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.84%
2/237 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.99%
2/202 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.88%
2/228 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
2.2%
5/229 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
3.4%
4/118 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Gastroenteritis
|
1.4%
3/222 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.82%
2/245 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.7%
4/237 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
2.0%
4/202 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
2.2%
5/228 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
1.9%
2/104 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/55 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
2.8%
4/145 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
COVID-19
|
1.4%
3/222 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.84%
2/237 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
2.5%
3/118 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.96%
1/104 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
2.1%
3/145 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Sinusitis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.82%
2/245 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.84%
2/237 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
2.0%
4/202 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.87%
2/229 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/56 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
1.9%
2/104 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/55 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
2.1%
3/145 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
7/222 • Number of events 8 • From first dose up to Week 62
Safety Analysis Set
|
2.4%
6/245 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
3.4%
8/237 • Number of events 9 • From first dose up to Week 62
Safety Analysis Set
|
4.5%
9/202 • Number of events 9 • From first dose up to Week 62
Safety Analysis Set
|
3.9%
9/228 • Number of events 11 • From first dose up to Week 62
Safety Analysis Set
|
7.4%
17/229 • Number of events 18 • From first dose up to Week 62
Safety Analysis Set
|
5.1%
6/118 • Number of events 11 • From first dose up to Week 62
Safety Analysis Set
|
7.1%
4/56 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
5.8%
6/104 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/55 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
6.2%
9/145 • Number of events 9 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Influenza
|
0.90%
2/222 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.41%
1/245 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.99%
2/202 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.88%
2/228 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.87%
2/229 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
3.6%
2/56 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.9%
2/104 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
2.1%
3/145 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
2.1%
3/145 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
4/222 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.41%
1/245 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
2.1%
5/237 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
2.0%
4/202 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
4.4%
10/228 • Number of events 11 • From first dose up to Week 62
Safety Analysis Set
|
3.9%
9/229 • Number of events 9 • From first dose up to Week 62
Safety Analysis Set
|
4.2%
5/118 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
2.9%
3/104 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/55 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
2.1%
3/145 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
1.4%
3/222 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
2.0%
5/245 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
0.42%
1/237 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
2.5%
5/202 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
4.4%
10/228 • Number of events 11 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/229 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
4.2%
5/118 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/56 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
1.9%
2/104 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
2.8%
4/145 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
3.8%
4/104 • Number of events 6 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
0.69%
1/145 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrheic keratosis
|
0.00%
0/222 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/245 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/202 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/228 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/229 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/104 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
2.1%
3/145 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
|
Vascular disorders
Hypertension
|
0.90%
2/222 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.2%
3/245 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
2.1%
5/237 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
2.0%
4/202 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/228 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.44%
1/229 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/118 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
2.9%
3/104 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/55 • From first dose up to Week 62
Safety Analysis Set
|
2.8%
4/145 • Number of events 4 • From first dose up to Week 62
Safety Analysis Set
|
|
General disorders
Asthenia
|
1.4%
3/222 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.82%
2/245 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.84%
2/237 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.99%
2/202 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/228 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
3.5%
8/229 • Number of events 9 • From first dose up to Week 62
Safety Analysis Set
|
1.7%
2/118 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/56 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
1.9%
2/104 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/55 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
1.4%
2/145 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
1.4%
3/222 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
0.82%
2/245 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/237 • From first dose up to Week 62
Safety Analysis Set
|
0.99%
2/202 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
1.3%
3/228 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
2.2%
5/229 • Number of events 5 • From first dose up to Week 62
Safety Analysis Set
|
0.85%
1/118 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
0.00%
0/56 • From first dose up to Week 62
Safety Analysis Set
|
2.9%
3/104 • Number of events 3 • From first dose up to Week 62
Safety Analysis Set
|
1.8%
1/55 • Number of events 1 • From first dose up to Week 62
Safety Analysis Set
|
1.4%
2/145 • Number of events 2 • From first dose up to Week 62
Safety Analysis Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
- Publication restrictions are in place
Restriction type: OTHER