Trial Outcomes & Findings for A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T) (NCT NCT01606761)
NCT ID: NCT01606761
Last Updated: 2018-03-23
Results Overview
The ACR 20 Response is defined as greater than or equal to (\>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \[0 =no pain to 10 =worst possible pain\]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
878 participants
Primary outcome timeframe
Week 16
Results posted on
2018-03-23
Participant Flow
A total of 878 participants (placebo \[n=294\], sirukumab 50 mg every 4 week (q4w) \[n=292\], and sirukumab 100 milligram (mg) every 2 week (q2w) \[n=292\]) were randomized and included in the study.
Participant milestones
| Measure |
Placebo
Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration before and up to Week 52 entered the safety follow-up period as well as those who completed through Week 52 were followed up for safety.
|
Sirukumab 50 mg q4w
All participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
Sirukumab 100 mg q2w
All participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
Placebo to 50 mg q4w Due to EE or CO
Participants who received matching placebo in the placebo controlled period were re-randomized (due to early escape \[EE\] at Week 18 or crossed over \[CO\] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
Placebo to 100 mg q2w Due to EE or CO
Participants who received matching placebo in the placebo controlled period were re-randomized (due to EE at Week 18 or CO at Week 24) to receive subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
|---|---|---|---|---|---|
|
Prior to Week 24
STARTED
|
294
|
292
|
292
|
0
|
0
|
|
Prior to Week 24
Participants Re-randomized at Week 18
|
94
|
0
|
0
|
0
|
0
|
|
Prior to Week 24
COMPLETED
|
252
|
237
|
245
|
0
|
0
|
|
Prior to Week 24
NOT COMPLETED
|
42
|
55
|
47
|
0
|
0
|
|
Week 24 to Week 52
STARTED
|
0
|
237
|
245
|
126
|
126
|
|
Week 24 to Week 52
Treated
|
0
|
237
|
245
|
124
|
126
|
|
Week 24 to Week 52
COMPLETED
|
0
|
204
|
212
|
109
|
106
|
|
Week 24 to Week 52
NOT COMPLETED
|
0
|
33
|
33
|
17
|
20
|
|
Safety Follow-up Period (Week 52-68)
STARTED
|
28
|
65
|
62
|
9
|
19
|
|
Safety Follow-up Period (Week 52-68)
Safety Population
|
28
|
65
|
62
|
7
|
19
|
|
Safety Follow-up Period (Week 52-68)
COMPLETED
|
24
|
55
|
45
|
7
|
11
|
|
Safety Follow-up Period (Week 52-68)
NOT COMPLETED
|
4
|
10
|
17
|
2
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration before and up to Week 52 entered the safety follow-up period as well as those who completed through Week 52 were followed up for safety.
|
Sirukumab 50 mg q4w
All participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
Sirukumab 100 mg q2w
All participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
Placebo to 50 mg q4w Due to EE or CO
Participants who received matching placebo in the placebo controlled period were re-randomized (due to early escape \[EE\] at Week 18 or crossed over \[CO\] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
Placebo to 100 mg q2w Due to EE or CO
Participants who received matching placebo in the placebo controlled period were re-randomized (due to EE at Week 18 or CO at Week 24) to receive subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
|---|---|---|---|---|---|
|
Prior to Week 24
Lost to Follow-up
|
0
|
3
|
2
|
0
|
0
|
|
Prior to Week 24
Withdrawal by Subject
|
12
|
10
|
9
|
0
|
0
|
|
Prior to Week 24
Adverse Event
|
11
|
18
|
22
|
0
|
0
|
|
Prior to Week 24
Lack of Efficacy
|
15
|
14
|
8
|
0
|
0
|
|
Prior to Week 24
Physician Decision
|
0
|
3
|
1
|
0
|
0
|
|
Prior to Week 24
Other
|
4
|
7
|
5
|
0
|
0
|
|
Week 24 to Week 52
Lost to Follow-up
|
0
|
1
|
1
|
1
|
0
|
|
Week 24 to Week 52
Withdrawal by Subject
|
0
|
6
|
3
|
0
|
0
|
|
Week 24 to Week 52
Adverse Event
|
0
|
11
|
14
|
3
|
15
|
|
Week 24 to Week 52
Death
|
0
|
0
|
2
|
1
|
0
|
|
Week 24 to Week 52
Lack of Efficacy
|
0
|
13
|
7
|
10
|
3
|
|
Week 24 to Week 52
Physician Decision
|
0
|
1
|
1
|
0
|
0
|
|
Week 24 to Week 52
Other
|
0
|
1
|
5
|
2
|
2
|
|
Safety Follow-up Period (Week 52-68)
Lost to Follow-up
|
0
|
1
|
2
|
0
|
1
|
|
Safety Follow-up Period (Week 52-68)
Withdrawal by Subject
|
4
|
6
|
6
|
1
|
3
|
|
Safety Follow-up Period (Week 52-68)
Death
|
0
|
0
|
0
|
0
|
1
|
|
Safety Follow-up Period (Week 52-68)
Other
|
0
|
3
|
9
|
1
|
3
|
Baseline Characteristics
A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)
Baseline characteristics by cohort
| Measure |
Placebo
n=294 Participants
Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration before and up to Week 52 entered the safety follow-up period as well as those who completed through Week 52 were followed up for safety.
|
Sirukumab 50 mg q4w
n=292 Participants
All participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
Sirukumab 100 mg q2w
n=292 Participants
All participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
Total
n=878 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
12.19 • n=5 Participants
|
0 Participants
11.89 • n=7 Participants
|
0 Participants
12.28 • n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
228 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
683 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
66 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
195 Participants
n=4 Participants
|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 12.19 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 11.89 • n=7 Participants
|
55 years
STANDARD_DEVIATION 12.28 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 12.11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
240 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
712 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Region of Enrollment
Lithuania
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
21 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Region of Enrollment
Portugal
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
Republic of Korea
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan, Province of China
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
148 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
445 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Efficacy full analysis set included all participants who were randomized into the study.
The ACR 20 Response is defined as greater than or equal to (\>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \[0 =no pain to 10 =worst possible pain\]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Outcome measures
| Measure |
Placebo
n=294 Participants
Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.
|
Sirukumab 50 mg
n=292 Participants
Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
|
Sirukumab 100 mg
n=292 Participants
Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
|
|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16
|
24.1 Percentage of Participants
|
40.1 Percentage of Participants
|
45.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Efficacy full analysis set included all participants who were randomized into the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.
The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Outcome measures
| Measure |
Placebo
n=294 Participants
Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.
|
Sirukumab 50 mg
n=291 Participants
Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
|
Sirukumab 100 mg
n=292 Participants
Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
|
|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24
Baseline
|
1.5663 Units on a scale
Standard Deviation 0.65223
|
1.6499 Units on a scale
Standard Deviation 0.59743
|
1.6122 Units on a scale
Standard Deviation 0.61320
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24
Change at Week 24
|
-0.12 Units on a scale
Standard Deviation 0.491
|
-0.31 Units on a scale
Standard Deviation 0.543
|
-0.33 Units on a scale
Standard Deviation 0.526
|
SECONDARY outcome
Timeframe: Week 24Population: Efficacy full analysis set included all participants who were randomized into the study.
The ACR 50 Response is defined as \>= 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS ( 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \[0 =no pain to 10 =worst possible pain\]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Outcome measures
| Measure |
Placebo
n=294 Participants
Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.
|
Sirukumab 50 mg
n=292 Participants
Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
|
Sirukumab 100 mg
n=292 Participants
Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
|
|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response at Week 24
|
8.8 Percentage of Participants
|
20.9 Percentage of Participants
|
21.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Efficacy full analysis set included all participants who were randomized into the study.
The Disease Activity Index Score 28 (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (\<) 2.6 at any study visit.
Outcome measures
| Measure |
Placebo
n=294 Participants
Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.
|
Sirukumab 50 mg
n=292 Participants
Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
|
Sirukumab 100 mg
n=292 Participants
Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
|
|---|---|---|---|
|
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 24
|
8.2 Percentage of Participants
|
19.2 Percentage of Participants
|
21.6 Percentage of Participants
|
Adverse Events
Week (W) 24-Placebo
Serious events: 15 serious events
Other events: 106 other events
Deaths: 0 deaths
W24 to W52-Placebo to 50 mg q4w Due to EE or CO
Serious events: 8 serious events
Other events: 50 other events
Deaths: 0 deaths
W52-Sirukumab 50 mg q4w
Serious events: 51 serious events
Other events: 152 other events
Deaths: 0 deaths
W24 to W52-Placebo to 100 mg q2w Due to EE or CO
Serious events: 18 serious events
Other events: 63 other events
Deaths: 0 deaths
W52-Sirukumab 100 mg q2w
Serious events: 37 serious events
Other events: 169 other events
Deaths: 0 deaths
W52 to W68-Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
W52 to W68-Placebo to 50 mg q4w Due to EE or CO
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
W52 to W68-Sirukumab 50 mg q4w
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
W52 to W68-Placebo to 100 mg q2w Due to EE or CO
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
W52 to W68-Sirukumab 100 mg q2w
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Week (W) 24-Placebo
n=294 participants at risk
Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossover (CO) at Week 24.
|
W24 to W52-Placebo to 50 mg q4w Due to EE or CO
n=124 participants at risk
Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape \[EE\] at Week 18 or crossed over \[CO\] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg q4w dose regimen up to Week 52.
|
W52-Sirukumab 50 mg q4w
n=292 participants at risk
Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
|
W24 to W52-Placebo to 100 mg q2w Due to EE or CO
n=126 participants at risk
Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape \[EE\] at Week 18 or crossed over \[CO\] at Week 24) to receive subcutaneous (SC) sirukumab 100 mg q4w dose regimen up to Week 52.
|
W52-Sirukumab 100 mg q2w
n=292 participants at risk
Participants received sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 52.
|
W52 to W68-Placebo
n=28 participants at risk
Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
W52 to W68-Placebo to 50 mg q4w Due to EE or CO
n=7 participants at risk
Participants who discontinued or completed sirukumab 50 mg q4w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
W52 to W68-Sirukumab 50 mg q4w
n=65 participants at risk
Participants who discontinued or completed sirukumab 50 mg q4w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
W52 to W68-Placebo to 100 mg q2w Due to EE or CO
n=19 participants at risk
Participants who discontinued or completed sirukumab 100 mg q2w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
W52 to W68-Sirukumab 100 mg q2w
n=62 participants at risk
Participants who discontinued or completed sirukumab 100 mg q2w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Blood and lymphatic system disorders
Normochromic Normocytic Anaemia
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.0%
3/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Cardiac disorders
Coronary Artery Disease
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Cardiac disorders
Myocardial Infarction
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Endocrine disorders
Goitre
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.81%
1/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Eye disorders
Diplopia
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.81%
1/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.3%
1/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Duodenal Ulcer Perforation
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Faecal Incontinence
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Gastric Ulcer Perforation
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Pancreatic Pseudocyst
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Tongue Ulceration
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
General disorders
Chest Pain
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.81%
1/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.68%
2/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
General disorders
Device Dislocation
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.68%
2/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
General disorders
Impaired Healing
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
General disorders
Sudden Death
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Immune system disorders
Food Allergy
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Abscess Jaw
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Alpha Haemolytic Streptococcal Infection
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Arthritis Infective
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.0%
3/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
2/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.68%
2/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Colonic Abscess
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Discomfort
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Cystitis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Diverticulitis
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.68%
2/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Empyema
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
2/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.3%
1/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Gastroenteritis
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Infectious Pleural Effusion
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Influenza
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Necrotising Fasciitis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.68%
2/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Peritonitis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Pneumonia
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.7%
5/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.7%
5/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Sepsis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Urinary Tract Infection
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Wound Infection Pseudomonas
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.68%
2/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Injury, poisoning and procedural complications
Periprosthetic Fracture
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.68%
2/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Investigations
Hepatic Enzyme Abnormal
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Investigations
Morganella Test Positive
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.68%
2/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.81%
1/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.0%
3/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.68%
2/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
2/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.0%
3/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.5%
1/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Necrosis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondroma
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative Disorder
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal Squamous Cell Carcinoma
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.81%
1/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenocarcinoma
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.81%
1/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.68%
2/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Nervous system disorders
Diabetic Neuropathy
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Missed
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Oedema
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Vascular disorders
Hypertension
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Vascular disorders
Intermittent Claudication
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Vascular disorders
Thrombosed Varicose Vein
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.81%
1/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
Other adverse events
| Measure |
Week (W) 24-Placebo
n=294 participants at risk
Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossover (CO) at Week 24.
|
W24 to W52-Placebo to 50 mg q4w Due to EE or CO
n=124 participants at risk
Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape \[EE\] at Week 18 or crossed over \[CO\] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg q4w dose regimen up to Week 52.
|
W52-Sirukumab 50 mg q4w
n=292 participants at risk
Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
|
W24 to W52-Placebo to 100 mg q2w Due to EE or CO
n=126 participants at risk
Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape \[EE\] at Week 18 or crossed over \[CO\] at Week 24) to receive subcutaneous (SC) sirukumab 100 mg q4w dose regimen up to Week 52.
|
W52-Sirukumab 100 mg q2w
n=292 participants at risk
Participants received sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 52.
|
W52 to W68-Placebo
n=28 participants at risk
Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
W52 to W68-Placebo to 50 mg q4w Due to EE or CO
n=7 participants at risk
Participants who discontinued or completed sirukumab 50 mg q4w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
W52 to W68-Sirukumab 50 mg q4w
n=65 participants at risk
Participants who discontinued or completed sirukumab 50 mg q4w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
W52 to W68-Placebo to 100 mg q2w Due to EE or CO
n=19 participants at risk
Participants who discontinued or completed sirukumab 100 mg q2w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
W52 to W68-Sirukumab 100 mg q2w
n=62 participants at risk
Participants who discontinued or completed sirukumab 100 mg q2w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
3.7%
11/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
2/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
4.5%
13/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
4.8%
6/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
6.5%
19/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.5%
1/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.5%
19/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
4.8%
6/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
8.2%
24/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
7.1%
9/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
8.9%
26/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Eye disorders
Blepharitis
|
0.34%
1/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.81%
1/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.3%
1/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Chronic Gastritis
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.3%
1/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Gastrointestinal disorders
Nausea
|
1.4%
4/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
2/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
3.4%
10/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
4.5%
13/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.3%
1/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
General disorders
Injection Site Erythema
|
1.4%
4/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
4.0%
5/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
9.6%
28/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
15.1%
19/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
16.1%
47/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
General disorders
Injection Site Pruritus
|
0.68%
2/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
3.2%
4/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
2.7%
8/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
7.9%
10/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
10.6%
31/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
General disorders
Injection Site Swelling
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
2/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.4%
4/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.6%
7/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
8.2%
24/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.3%
1/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Bronchitis
|
1.7%
5/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.6%
7/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
4.5%
13/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
3.2%
4/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
7.5%
22/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
14.3%
1/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Conjunctivitis Bacterial
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.3%
1/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
11/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
2/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
11.6%
34/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.6%
7/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
8.9%
26/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.81%
1/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.0%
3/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
2/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.7%
5/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
14.3%
1/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Infections and infestations
Sinusitis
|
2.7%
8/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
4.0%
5/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
4.8%
14/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
2.4%
3/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.1%
15/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Investigations
Alanine Aminotransferase Increased
|
2.0%
6/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
9.7%
12/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
9.2%
27/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
6.3%
8/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
7.9%
23/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.5%
1/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.3%
1/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
1/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Investigations
Aspartate Aminotransferase Increased
|
1.4%
4/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
4.8%
6/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
6.2%
18/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
4.0%
5/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.1%
15/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.5%
1/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.3%
1/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
1/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Investigations
Hepatitis B Dna Assay Positive
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.3%
1/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Investigations
Lymphocyte Count Increased
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
14.3%
1/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Investigations
Neutrophil Count Increased
|
0.68%
2/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.81%
1/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
14.3%
1/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Investigations
White Blood Cell Count Increased
|
0.68%
2/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.81%
1/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
14.3%
1/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Investigations
X-Ray with Contrast Upper Gastrointestinal Tract Abnormal
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.3%
1/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.0%
3/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
2/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.0%
3/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
14.3%
1/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.68%
2/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
2.4%
7/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
3.1%
9/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
14.3%
1/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.68%
2/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
2/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.7%
5/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.79%
1/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
2.4%
7/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
14.3%
1/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
1/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
9.5%
28/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
10.5%
13/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
10.3%
30/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
3.2%
4/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
10.3%
30/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
1/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.68%
2/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
3.2%
4/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
4.5%
13/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
3.2%
4/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
7.5%
22/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
14.3%
1/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Pruritus
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.3%
1/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Skin and subcutaneous tissue disorders
Eczema Asteatotic
|
0.00%
0/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.34%
1/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.3%
1/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
3/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
2/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
3.1%
9/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.1%
15/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
|
Vascular disorders
Hypertension
|
2.4%
7/294 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
2.4%
3/124 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.8%
17/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
2.4%
3/126 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
5.1%
15/292 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/28 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/7 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/65 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
0.00%
0/19 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
1.6%
1/62 • Up to Week 68
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
|
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