Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI) (NCT NCT01369355)
NCT ID: NCT01369355
Last Updated: 2025-02-04
Results Overview
Clinical remission at Week 44 was defined as a Crohn's Disease Activity Index (CDAI) score of \<150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1282 participants
Primary outcome timeframe
Week 44
Results posted on
2025-02-04
Participant Flow
Out of 1282 participants enrolled,1 was excluded from study before assignment to arm/group due to deviation from Good Clinical Practice at 1 study site. Hence 1281 participants were analyzed. Total 397 participants who were in clinical response to ustekinumab induction were randomized in maintenance study and considered as primary population.
Due to a stability issue with the batch of Intravenous (IV) drug (130 mg ustekinumab), in November 2011 sponsor temporarily suspended dosing in induction studies (CRD3001 and CRD3002) and this maintenance study (CRD3003). All 3 studies were restarted with a 90 milligram per milliliter (mg/mL) formulation for IV administration on 17 February 2012.
Participant milestones
| Measure |
Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
|
UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.
|
UST-I-Rsp-UST-90 mg Q8W Maintenance
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
|
Placebo (PBO)-I-Rsp - PBO Maintenance
Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study; not randomized.
|
PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance
Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received ustekinumab 130 mg IV on entry into maintenance followed by ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.
|
UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance
Participants (who were not in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab 90 mg SC on entry into maintenance followed by ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.
|
Placebo Long Term Extension (LTE)
Participants who received placebo SC in the maintenance study, entered the LTE and continued to receive placebo SC in the LTE study (Week 44 to 272).
|
UST 90 mg SC Q12W LTE
Participants entered the LTE and continued to receive ustekinumab 90 mg SC q12w in the LTE study (Week 44 to 272).
|
UST 90 mg SC Q8W LTE
Participants entered the LTE and continued to receive ustekinumab 90 mg SC q8w in the LTE study (Week 44 to 272).
|
|---|---|---|---|---|---|---|---|---|---|
|
Week 0 - Week 44 (Maintenance)
STARTED
|
133
|
132
|
132
|
123
|
285
|
476
|
0
|
0
|
0
|
|
Week 0 - Week 44 (Maintenance)
COMPLETED
|
102
|
103
|
101
|
93
|
131
|
204
|
0
|
0
|
0
|
|
Week 0 - Week 44 (Maintenance)
NOT COMPLETED
|
31
|
29
|
31
|
30
|
154
|
272
|
0
|
0
|
0
|
|
Long-term Extension (Week 44-272)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
151
|
213
|
354
|
|
Long-term Extension (Week 44-272)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
107
|
183
|
|
Long-term Extension (Week 44-272)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
151
|
106
|
171
|
Reasons for withdrawal
| Measure |
Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
|
UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.
|
UST-I-Rsp-UST-90 mg Q8W Maintenance
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
|
Placebo (PBO)-I-Rsp - PBO Maintenance
Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study; not randomized.
|
PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance
Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received ustekinumab 130 mg IV on entry into maintenance followed by ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.
|
UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance
Participants (who were not in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab 90 mg SC on entry into maintenance followed by ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.
|
Placebo Long Term Extension (LTE)
Participants who received placebo SC in the maintenance study, entered the LTE and continued to receive placebo SC in the LTE study (Week 44 to 272).
|
UST 90 mg SC Q12W LTE
Participants entered the LTE and continued to receive ustekinumab 90 mg SC q12w in the LTE study (Week 44 to 272).
|
UST 90 mg SC Q8W LTE
Participants entered the LTE and continued to receive ustekinumab 90 mg SC q8w in the LTE study (Week 44 to 272).
|
|---|---|---|---|---|---|---|---|---|---|
|
Week 0 - Week 44 (Maintenance)
Adverse Event
|
9
|
12
|
6
|
7
|
14
|
25
|
0
|
0
|
0
|
|
Week 0 - Week 44 (Maintenance)
Lack of Efficacy
|
15
|
14
|
15
|
15
|
126
|
217
|
0
|
0
|
0
|
|
Week 0 - Week 44 (Maintenance)
Protocol Violation
|
0
|
1
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Week 0 - Week 44 (Maintenance)
Lost to Follow-up
|
1
|
0
|
1
|
2
|
5
|
6
|
0
|
0
|
0
|
|
Week 0 - Week 44 (Maintenance)
Withdrawal by Subject
|
6
|
2
|
7
|
6
|
8
|
22
|
0
|
0
|
0
|
|
Week 0 - Week 44 (Maintenance)
Other
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Long-term Extension (Week 44-272)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
29
|
53
|
|
Long-term Extension (Week 44-272)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
|
Long-term Extension (Week 44-272)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
26
|
29
|
|
Long-term Extension (Week 44-272)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Long-term Extension (Week 44-272)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
5
|
11
|
|
Long-term Extension (Week 44-272)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
5
|
9
|
|
Long-term Extension (Week 44-272)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
30
|
47
|
|
Long-term Extension (Week 44-272)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
110
|
9
|
17
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)
Baseline characteristics by cohort
| Measure |
Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance
n=133 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
|
UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance
n=132 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.
|
UST-I-Rsp-UST-90 mg Q8W Maintenance
n=132 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
|
Placebo (PBO)-I-Rsp - PBO Maintenance
n=123 Participants
Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study; not randomized.
|
PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance
n=285 Participants
Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received ustekinumab 130 mg IV on entry into maintenance followed by ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.
|
UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance
n=476 Participants
Participants (who were not in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab 90 mg SC on entry into maintenance followed by ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.
|
Total
n=1281 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 12.69 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 13.65 • n=7 Participants
|
37.9 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
39.1 years
STANDARD_DEVIATION 12.46 • n=4 Participants
|
39 years
STANDARD_DEVIATION 12.33 • n=21 Participants
|
37.4 years
STANDARD_DEVIATION 12.5 • n=8 Participants
|
38.3 years
STANDARD_DEVIATION 12.68 • n=8 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
149 Participants
n=21 Participants
|
275 Participants
n=8 Participants
|
712 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
201 Participants
n=8 Participants
|
569 Participants
n=8 Participants
|
|
Region of Enrollment
Australia
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
38 Participants
n=8 Participants
|
|
Region of Enrollment
Austria
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Region of Enrollment
Belgium
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
|
Region of Enrollment
Bulgaria
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Region of Enrollment
Brazil
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
92 Participants
n=8 Participants
|
|
Region of Enrollment
Denmark
|
1 Participants
n=5 Participants
|
2 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
Spain
|
1 Participants
n=5 Participants
|
0 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
France
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
64 Participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
67 Participants
n=8 Participants
|
|
Region of Enrollment
Croatia
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Region of Enrollment
Hungary
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
64 Participants
n=8 Participants
|
|
Region of Enrollment
Ireland
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
Iceland
|
1 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
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
Israel
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
74 Participants
n=8 Participants
|
|
Region of Enrollment
Korea, Democratic People'S Republic Of
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Region of Enrollment
Netherlands
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Region of Enrollment
New Zealand
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Region of Enrollment
Poland
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Region of Enrollment
Russia
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
|
Region of Enrollment
Serbia
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
124 Participants
n=21 Participants
|
198 Participants
n=8 Participants
|
495 Participants
n=8 Participants
|
|
Region of Enrollment
South Africa
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
|
Region of Enrollment
Czech Republic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
84 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 44Population: The primary efficacy analysis population in this study was randomized participants (i.e., participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.
Clinical remission at Week 44 was defined as a Crohn's Disease Activity Index (CDAI) score of \<150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity.
Outcome measures
| Measure |
Placebo Subcutaneously (SC)
n=131 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
|
Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)
n=129 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q12w in the maintenance study.
|
Ustekinumab 90 mg SC q8w
n=128 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
|
|---|---|---|---|
|
Number of Participants With Clinical Remission at Week 44
|
47 participants
|
63 participants
|
68 participants
|
SECONDARY outcome
Timeframe: Week 44Population: The primary efficacy analysis population in this study was randomized participants (i.e., participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.
Clinical response at Week 44 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (\>=) 100 points. Participants with a baseline CDAI score of \> = 220 to less than or equal (\< =) 248 were considered to be in clinical response if a CDAI score of less than (\<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.
Outcome measures
| Measure |
Placebo Subcutaneously (SC)
n=131 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
|
Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)
n=129 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q12w in the maintenance study.
|
Ustekinumab 90 mg SC q8w
n=128 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
|
|---|---|---|---|
|
Number of Participants With Clinical Response at Week 44
|
58 participants
|
75 participants
|
76 participants
|
SECONDARY outcome
Timeframe: Week 44Population: Analysis population included all randomized participants after the study was restarted (who were in clinical remission at Week 0 of maintenance study). 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Clinical remission at week 44 was defined as a CDAI score of \< 150 points among participants in clinical remission to ustekinumab at week 0 of maintenance study.
Outcome measures
| Measure |
Placebo Subcutaneously (SC)
n=79 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
|
Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)
n=78 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q12w in the maintenance study.
|
Ustekinumab 90 mg SC q8w
n=78 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
|
|---|---|---|---|
|
Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study
|
36 participants
|
44 participants
|
52 participants
|
SECONDARY outcome
Timeframe: Week 44Population: The primary efficacy analysis population in this study was randomized participants (i.e., participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.
Corticosteroid-free remission at Week 44 was defined as a CDAI score of \<150 points without receiving corticosteroids at Week 44.
Outcome measures
| Measure |
Placebo Subcutaneously (SC)
n=131 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
|
Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)
n=129 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q12w in the maintenance study.
|
Ustekinumab 90 mg SC q8w
n=128 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
|
|---|---|---|---|
|
Number of Participants With Corticosteroid-free Remission at Week 44
|
39 participants
|
55 participants
|
60 participants
|
SECONDARY outcome
Timeframe: Week 44Population: The primary efficacy analysis population in this study was randomized participants (i.e., participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.
Clinical remission at Week 44 was defined as a CDAI score of \<150 points in the subset of participants who were refractory or Intolerant to tumor necrosis factor antagonist therapy.
Outcome measures
| Measure |
Placebo Subcutaneously (SC)
n=61 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
|
Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)
n=57 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q12w in the maintenance study.
|
Ustekinumab 90 mg SC q8w
n=56 Participants
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive ustekinumab SC 90 mg q8w in the maintenance study.
|
|---|---|---|---|
|
Number of Participants in Clinical Remission at Week 44 in the Subset of Participants Who Were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy
|
16 participants
|
22 participants
|
23 participants
|
Adverse Events
Ustekinumab Induction Responders(USTIRsp) Placebo Maintenance
Serious events: 22 serious events
Other events: 94 other events
Deaths: 0 deaths
UST -I-Rsp -PBO Maintenance -UST-90mg SC Q8W- Maintenance
Serious events: 7 serious events
Other events: 34 other events
Deaths: 0 deaths
UST-I-Rsp-UST 90 mg SC Every 12 Weeks (Q12W) Maintenance
Serious events: 16 serious events
Other events: 88 other events
Deaths: 0 deaths
UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
UST-I-Rsp-UST 90 mg SC Q8W Maintenance
Serious events: 13 serious events
Other events: 84 other events
Deaths: 0 deaths
UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo (PBO)-I-Rsp PBO Maintenance
Serious events: 19 serious events
Other events: 82 other events
Deaths: 0 deaths
PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance
Serious events: 47 serious events
Other events: 160 other events
Deaths: 0 deaths
UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance
Serious events: 77 serious events
Other events: 275 other events
Deaths: 0 deaths
Placebo Long Term Extension (LTE)
Serious events: 26 serious events
Other events: 83 other events
Deaths: 0 deaths
UST 90 mg SC Q12W LTE
Serious events: 68 serious events
Other events: 162 other events
Deaths: 2 deaths
UST 90 mg SC Q8W LTE
Serious events: 99 serious events
Other events: 293 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Ustekinumab Induction Responders(USTIRsp) Placebo Maintenance
n=133 participants at risk
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study (includes events up to the time of loss of response).
|
UST -I-Rsp -PBO Maintenance -UST-90mg SC Q8W- Maintenance
n=51 participants at risk
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received placebo SC and had dose adjustment to ustekinumab SC 90 mg q8w (includes events from the time of loss of response onward).
|
UST-I-Rsp-UST 90 mg SC Every 12 Weeks (Q12W) Maintenance
n=132 participants at risk
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 milligrams (mg) q12w in the maintenance study (includes events up to the time of loss of response).
|
UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance
n=29 participants at risk
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 mg q12w and had dose adjustment to ustekinumab SC 90 mg q8w in the maintenance study (includes events from the time of loss of response onward).
|
UST-I-Rsp-UST 90 mg SC Q8W Maintenance
n=131 participants at risk
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 mg q8w (includes events up to the time of loss of response).
|
UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance
n=29 participants at risk
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 mg q8 weeks and remained on ustekinumab 90 mg q8w upon loss of response (includes events from the time of loss of response onward).
|
Placebo (PBO)-I-Rsp PBO Maintenance
n=123 participants at risk
Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC; not randomized.
|
PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance
n=285 participants at risk
Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received ustekinumab 130 mg IV on entry into maintenance followed by ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.
|
UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance
n=476 participants at risk
Participants (who were not in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab 90 mg SC on entry into maintenance followed by ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.
|
Placebo Long Term Extension (LTE)
n=151 participants at risk
Participants who received placebo SC in the maintenance study, entered the LTE and continued to receive placebo SC in the LTE study (Week 44 to 272).
|
UST 90 mg SC Q12W LTE
n=213 participants at risk
Participants entered the LTE and continued to receive ustekinumab 90 mg SC q12w in the LTE study (Week 44 to 272).
|
UST 90 mg SC Q8W LTE
n=354 participants at risk
Participants entered the LTE and continued to receive ustekinumab 90 mg SC q8w in the LTE study (Week 44 to 272).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.94%
2/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.94%
2/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Congenital, familial and genetic disorders
Fibrous Dysplasia of Bone
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Eye disorders
Strabismus
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Abdominal Adhesions
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.3%
2/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.4%
5/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.81%
1/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Anal Fistula
|
1.5%
2/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.70%
2/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Colon Dysplasia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.81%
1/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Crohn's Disease
|
5.3%
7/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
7.8%
4/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.8%
5/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.3%
3/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.1%
4/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.3%
3/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.9%
6/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.3%
15/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.3%
30/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
7.9%
12/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.0%
17/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
9.0%
32/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Cyclic Vomiting Syndrome
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Enterocutaneous Fistula
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Enterovesical Fistula
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Epiploic Appendagitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.70%
2/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Fistula of Small Intestine
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.4%
3/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Ileal Stenosis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Inflammatory Bowel Disease
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Intestinal Stenosis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.42%
2/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.56%
2/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Large Intestinal Stenosis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.5%
2/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Mallory-Weiss Syndrome
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.81%
1/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Oesophageal Stenosis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Rectal Prolapse
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Rectal Stenosis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.81%
1/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.70%
2/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.1%
10/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.6%
4/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.8%
6/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.8%
10/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Small Intestinal Perforation
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Small Intestinal Stenosis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Tooth Impacted
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
General disorders
Asthenia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
General disorders
Chest Pain
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
General disorders
Dysplasia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
General disorders
Incarcerated Hernia
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.42%
2/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.56%
2/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
General disorders
Oedema Peripheral
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
General disorders
Pyrexia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.56%
2/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
General disorders
Sudden Death
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.81%
1/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.85%
3/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.94%
2/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Abscess Intestinal
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Anal Abscess
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.81%
1/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.1%
3/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.63%
3/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.8%
6/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.85%
3/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Anal Fistula Infection
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.5%
2/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Campylobacter Gastroenteritis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.94%
2/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.81%
1/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Cytomegalovirus Colitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Cytomegalovirus Viraemia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.56%
2/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.56%
2/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Hepatitis Infectious Mononucleosis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Influenza
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Liver Abscess
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Mastitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Myringitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Ophthalmic Herpes Zoster
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Perirectal Abscess
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.56%
2/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Peritonitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Pneumonia
|
1.5%
2/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.94%
2/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.56%
2/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Pneumonia Staphylococcal
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Postoperative Abscess
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Pseudomembranous Colitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.56%
2/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Rectal Abscess
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Sepsis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Septic Shock
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Tubo-Ovarian Abscess
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Vaginal Abscess
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Vascular Device Infection
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Viral Infection
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Wound Abscess
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Allergic Transfusion Reaction
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Anastomotic Haemorrhage
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.81%
1/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Anastomotic Leak
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Gastrointestinal Anastomotic Stenosis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Heat Stroke
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Intestinal Anastomosis Complication
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Muscle Injury
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Procedural Intestinal Perforation
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Sternal Injury
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Investigations
Blood Electrolytes Abnormal
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Investigations
Electrocardiogram Abnormal
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Investigations
Faecal Volume Increased
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Investigations
Troponin Increased
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.94%
2/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.85%
3/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.70%
2/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Dactylitis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Space Narrowing
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.85%
3/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.81%
1/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Thyroid Gland
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Myeloid Leukaemia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Adenocarcinoma
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of Breast
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.81%
1/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo Maligna
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Adenoma
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Intestine Adenocarcinoma
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Dementia with Lewy Bodies
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Headache
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Idiopathic Intracranial Hypertension
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Intracranial Aneurysm
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Migraine
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Seizure
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Syncope
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.56%
2/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.4%
3/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.85%
3/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Pregnancy, puerperium and perinatal conditions
Premature Delivery
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Pregnancy, puerperium and perinatal conditions
Premature Labour
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Psychiatric disorders
Depression
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Renal and urinary disorders
End Stage Renal Disease
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.94%
2/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Renal and urinary disorders
Renal Tubular Necrosis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Reproductive system and breast disorders
Bartholin's Cyst
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Reproductive system and breast disorders
Female Genital Tract Fistula
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.81%
1/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Reproductive system and breast disorders
Pelvic Congestion
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Polyps
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.81%
1/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Granuloma
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haematoma
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Skin and subcutaneous tissue disorders
Pustular Psoriasis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson Syndrome
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Social circumstances
Breast Prosthesis User
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.81%
1/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Social circumstances
Miscarriage of Partner
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.81%
1/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Social circumstances
Substance Abuser
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Surgical and medical procedures
Abdominal Hernia Repair
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Surgical and medical procedures
Ileostomy Closure
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Surgical and medical procedures
Pelvic Pouch Procedure
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Surgical and medical procedures
Rotator Cuff Repair
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Vascular disorders
Aortic Dissection
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Vascular disorders
Aortic Stenosis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.42%
2/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.56%
2/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Vascular disorders
Essential Hypertension
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Vascular disorders
Hypertension
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.28%
1/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Vascular disorders
Hypertensive Urgency
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
Other adverse events
| Measure |
Ustekinumab Induction Responders(USTIRsp) Placebo Maintenance
n=133 participants at risk
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study (includes events up to the time of loss of response).
|
UST -I-Rsp -PBO Maintenance -UST-90mg SC Q8W- Maintenance
n=51 participants at risk
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received placebo SC and had dose adjustment to ustekinumab SC 90 mg q8w (includes events from the time of loss of response onward).
|
UST-I-Rsp-UST 90 mg SC Every 12 Weeks (Q12W) Maintenance
n=132 participants at risk
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 milligrams (mg) q12w in the maintenance study (includes events up to the time of loss of response).
|
UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance
n=29 participants at risk
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 mg q12w and had dose adjustment to ustekinumab SC 90 mg q8w in the maintenance study (includes events from the time of loss of response onward).
|
UST-I-Rsp-UST 90 mg SC Q8W Maintenance
n=131 participants at risk
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 mg q8w (includes events up to the time of loss of response).
|
UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance
n=29 participants at risk
Participants (who were in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab SC 90 mg q8 weeks and remained on ustekinumab 90 mg q8w upon loss of response (includes events from the time of loss of response onward).
|
Placebo (PBO)-I-Rsp PBO Maintenance
n=123 participants at risk
Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC; not randomized.
|
PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance
n=285 participants at risk
Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received ustekinumab 130 mg IV on entry into maintenance followed by ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.
|
UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance
n=476 participants at risk
Participants (who were not in clinical response to ustekinumab IV at Week 8 of an induction study) received ustekinumab 90 mg SC on entry into maintenance followed by ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.
|
Placebo Long Term Extension (LTE)
n=151 participants at risk
Participants who received placebo SC in the maintenance study, entered the LTE and continued to receive placebo SC in the LTE study (Week 44 to 272).
|
UST 90 mg SC Q12W LTE
n=213 participants at risk
Participants entered the LTE and continued to receive ustekinumab 90 mg SC q12w in the LTE study (Week 44 to 272).
|
UST 90 mg SC Q8W LTE
n=354 participants at risk
Participants entered the LTE and continued to receive ustekinumab 90 mg SC q8w in the LTE study (Week 44 to 272).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.8%
5/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.3%
3/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.1%
5/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.1%
6/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.3%
11/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.3%
2/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
7.0%
15/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.8%
17/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.8%
17/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.9%
3/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
9.1%
12/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
17.2%
5/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.4%
11/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
12.2%
15/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.1%
23/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.0%
38/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.6%
16/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
17.8%
38/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
19.2%
68/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.3%
3/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.0%
4/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.5%
2/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.1%
5/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.8%
8/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.2%
15/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.3%
8/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.2%
11/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.2%
22/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Constipation
|
3.0%
4/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.5%
6/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.3%
3/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.1%
6/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.1%
10/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.2%
9/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.2%
22/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Crohn's Disease
|
9.0%
12/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
9.8%
5/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
9.1%
12/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.3%
3/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
9.2%
12/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.6%
13/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.0%
17/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.4%
40/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
16.6%
25/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
20.7%
44/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
22.6%
80/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
7/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.9%
2/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.3%
11/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.8%
5/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.9%
11/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.5%
10/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.5%
12/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
7.3%
11/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
14.1%
30/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
14.1%
50/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.5%
2/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.9%
2/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.6%
2/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.4%
4/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.5%
7/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.3%
2/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.2%
11/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.2%
15/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Nausea
|
6.8%
9/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.9%
3/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
7.6%
10/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.3%
3/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.1%
4/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
9.8%
12/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.3%
15/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
9.7%
46/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
7.9%
12/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.8%
23/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
9.6%
34/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
9/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.9%
3/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.8%
5/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.1%
4/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.1%
5/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.1%
6/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
33/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.3%
2/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.6%
14/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
7.3%
26/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
General disorders
Fatigue
|
4.5%
6/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.9%
2/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.1%
8/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.6%
6/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
7.3%
9/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.9%
11/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.2%
15/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.3%
8/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.1%
13/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.2%
29/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
General disorders
Injection Site Erythema
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.3%
7/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.6%
2/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.8%
5/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.5%
7/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.3%
7/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
7/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
General disorders
Pyrexia
|
8.3%
11/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.9%
2/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.3%
11/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.3%
3/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
9/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
9.8%
12/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.6%
16/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.3%
25/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.0%
9/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.9%
19/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.4%
19/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Bronchitis
|
3.0%
4/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.9%
3/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.6%
6/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.4%
3/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.8%
5/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.5%
7/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.6%
4/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.1%
13/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.5%
30/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Gastroenteritis
|
3.8%
5/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.3%
3/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.1%
4/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.3%
4/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.8%
8/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.8%
18/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.6%
7/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
9.9%
21/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
11.6%
41/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Gastroenteritis Viral
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.9%
3/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.0%
4/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.1%
4/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.1%
5/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.1%
6/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.3%
6/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.3%
2/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.2%
11/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
12/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Influenza
|
3.0%
4/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.1%
8/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.8%
5/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.3%
4/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.2%
9/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.7%
8/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.6%
4/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
11.7%
25/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.5%
37/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
10/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
7.8%
4/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
12.9%
17/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
13.8%
4/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.7%
14/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
12.2%
15/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
11.2%
32/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.9%
52/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.6%
16/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
25.4%
54/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
28.2%
100/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Pharyngitis Streptococcal
|
1.5%
2/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.6%
2/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.1%
3/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.21%
1/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.94%
2/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.85%
3/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Sinusitis
|
1.5%
2/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.5%
6/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.1%
4/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.1%
5/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.2%
12/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.6%
17/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.3%
8/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.9%
19/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.2%
36/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
15.8%
21/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.8%
9/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
9.9%
13/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.7%
7/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.8%
25/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
33/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
9.3%
14/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
18.8%
40/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
17.5%
62/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Infections and infestations
Urinary Tract Infection
|
2.3%
3/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.8%
9/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.1%
4/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.7%
7/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.8%
5/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.6%
17/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.6%
7/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
7.0%
15/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
9.9%
35/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.6%
2/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.35%
1/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.1%
5/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.3%
5/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.3%
5/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.4%
5/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.5%
18/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
11.8%
6/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
16.7%
22/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
17.2%
5/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
13.7%
18/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.3%
3/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
18.7%
23/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.2%
29/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.3%
49/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
7.3%
11/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
12.7%
27/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
11.3%
40/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.3%
3/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.3%
3/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.5%
8/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.5%
7/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.63%
3/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.1%
4/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.5%
6/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.9%
2/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.8%
5/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.6%
6/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
10.3%
3/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.6%
2/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.2%
12/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.2%
15/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.6%
13/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.5%
18/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
13.6%
48/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.8%
5/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.4%
4/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.3%
6/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.2%
9/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.1%
18/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Nervous system disorders
Headache
|
11.3%
15/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
11.8%
6/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
11.4%
15/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
11.5%
15/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
13.0%
16/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
7.4%
21/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.6%
41/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
7.9%
12/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
8.9%
19/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
11.3%
40/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Psychiatric disorders
Anxiety
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.5%
2/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.4%
4/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.63%
3/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.66%
1/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.8%
6/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
12/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
3/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.0%
1/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.0%
4/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.3%
7/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.9%
6/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.2%
9/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.5%
26/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.3%
8/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.1%
13/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.8%
24/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.0%
4/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.9%
2/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.5%
2/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.3%
3/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.6%
2/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.8%
8/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.7%
13/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.7%
10/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
12/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.9%
3/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.76%
1/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.5%
2/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.8%
5/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.5%
7/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.3%
2/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.8%
6/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
2.5%
9/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.8%
5/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.9%
2/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.0%
4/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.4%
1/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.3%
7/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.1%
5/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.8%
5/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
4.6%
22/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
3.3%
5/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.6%
12/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
5.6%
20/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.75%
1/133 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/51 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.5%
2/132 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/131 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
6.9%
2/29 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
1.6%
2/123 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.70%
2/285 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.63%
3/476 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.00%
0/151 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.47%
1/213 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
0.56%
2/354 • Up to Week 272
Safety was analyzed for all treated participants who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER