Trial Outcomes & Findings for A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy (NCT NCT00718718)
NCT ID: NCT00718718
Last Updated: 2018-01-23
Results Overview
An American College of Rheumatology (ACR) 50 response is defined as greater than or equal to (\>=) 50 percent (%) improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and \>= 50% improvement in 3 of the following 5 assessments: participant's assessment of pain using Visual Analogue Scale (Score) VAS (0-10 scale, 0=no pain and 10=worst possible pain), participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \[0 = very well to 10 = very poor\]), physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, \[0=no arthritis activity to 10=extremely active arthritis\]), participant's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, the scale 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
PHASE2
Target enrollment
187 participants
Primary outcome timeframe
Week 12
Results posted on
2018-01-23
Participant Flow
Participant milestones
| Measure |
Part A - Placebo (Wk 0-Wk 12)
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks.
|
Part A - Placebo Then Sirukumab (Wk 12 to End of Study)
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
|
Part A - Sirukumab (Wk 0-Wk 12)
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10.
|
Part A - Sirukumab Then Placebo (Wk 12 to End of Study)
Participants received placebo at Weeks 12 and q2w through Week 22.
|
Part B - Placebo (Wk 0-Wk 12)
Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks.
|
Part B - Placebo Then Sirukumab 100 mg q2 Weeks
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24.
|
Part B - Sirukumab 100mg q2w
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
|
Part B - Sirukumab 100mg q4w
Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
|
Part B - Sirukumab 50mg q4w
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Prior to Week 12
STARTED
|
19
|
0
|
17
|
0
|
30
|
0
|
30
|
30
|
30
|
31
|
|
Prior to Week 12
COMPLETED
|
18
|
0
|
16
|
0
|
27
|
0
|
29
|
28
|
28
|
31
|
|
Prior to Week 12
NOT COMPLETED
|
1
|
0
|
1
|
0
|
3
|
0
|
1
|
2
|
2
|
0
|
|
Week 12 to End of Study
STARTED
|
0
|
18
|
0
|
16
|
0
|
27
|
29
|
28
|
28
|
31
|
|
Week 12 to End of Study
Treated
|
0
|
18
|
0
|
16
|
0
|
26
|
29
|
28
|
28
|
31
|
|
Week 12 to End of Study
COMPLETED
|
0
|
17
|
0
|
15
|
0
|
24
|
27
|
27
|
27
|
31
|
|
Week 12 to End of Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
3
|
2
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part A - Placebo (Wk 0-Wk 12)
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks.
|
Part A - Placebo Then Sirukumab (Wk 12 to End of Study)
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
|
Part A - Sirukumab (Wk 0-Wk 12)
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10.
|
Part A - Sirukumab Then Placebo (Wk 12 to End of Study)
Participants received placebo at Weeks 12 and q2w through Week 22.
|
Part B - Placebo (Wk 0-Wk 12)
Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks.
|
Part B - Placebo Then Sirukumab 100 mg q2 Weeks
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24.
|
Part B - Sirukumab 100mg q2w
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
|
Part B - Sirukumab 100mg q4w
Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
|
Part B - Sirukumab 50mg q4w
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Prior to Week 12
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Prior to Week 12
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
0
|
1
|
1
|
1
|
0
|
|
Prior to Week 12
Other
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Week 12 to End of Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Week 12 to End of Study
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Week 12 to End of Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
|
Week 12 to End of Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Week 12 to End of Study
Other
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Baseline characteristics by cohort
| Measure |
Part A: Placebo
n=19 Participants
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
|
Part A: Sirukumab 100 mg q2 Weeks
n=17 Participants
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Week 12 and q2w through week 22.
|
Part B: Placebo
n=30 Participants
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
|
Part B: Sirukumab 100 mg q2 Weeks
n=30 Participants
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
|
Part B: Sirukumab 100 mg q4 Weeks
n=30 Participants
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 50 mg q4 Weeks
n=30 Participants
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
n=31 Participants
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 10.24 • n=5 Participants
|
50.1 years
STANDARD_DEVIATION 10.72 • n=7 Participants
|
54.1 years
STANDARD_DEVIATION 12.72 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 13.02 • n=4 Participants
|
52 years
STANDARD_DEVIATION 11 • n=21 Participants
|
50.9 years
STANDARD_DEVIATION 10.29 • n=8 Participants
|
52.8 years
STANDARD_DEVIATION 9.41 • n=8 Participants
|
51.8 years
STANDARD_DEVIATION 11.26 • n=24 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
153 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
34 Participants
n=24 Participants
|
|
Region of Enrollment
Hungary
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
|
Region of Enrollment
Japan
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
|
Region of Enrollment
Mexico
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
|
Region of Enrollment
Poland
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
62 Participants
n=24 Participants
|
|
Region of Enrollment
Republic of Korea
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Region of Enrollment
Russian Federation
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
41 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Population analyzed included all randomized participants in Part B.
An American College of Rheumatology (ACR) 50 response is defined as greater than or equal to (\>=) 50 percent (%) improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and \>= 50% improvement in 3 of the following 5 assessments: participant's assessment of pain using Visual Analogue Scale (Score) VAS (0-10 scale, 0=no pain and 10=worst possible pain), participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \[0 = very well to 10 = very poor\]), physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, \[0=no arthritis activity to 10=extremely active arthritis\]), participant's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, the scale 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 |
Part B: Placebo
n=30 Participants
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
|
Part B: Sirukumab 100 mg q2 Weeks
n=30 Participants
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
|
Part B: Sirukumab 100 mg q4 Weeks
n=30 Participants
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 50 mg q4 Weeks
n=30 Participants
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
n=31 Participants
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 50 mg q4 Weeks
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B)
|
3.3 Percentage of Participants
|
26.7 Percentage of Participants
|
23.3 Percentage of Participants
|
26.7 Percentage of Participants
|
19.4 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Population analyzed included randomized subjects in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'n' signifies participants who were evaluable at specific time points, for each arm, respectively.
The 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. A negative change from baseline in DAS28 (CRP) (that is, a decrease from baseline) indicates improvement from baseline.
Outcome measures
| Measure |
Part B: Placebo
n=19 Participants
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
|
Part B: Sirukumab 100 mg q2 Weeks
n=17 Participants
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
|
Part B: Sirukumab 100 mg q4 Weeks
n=30 Participants
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 50 mg q4 Weeks
n=30 Participants
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
n=30 Participants
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 50 mg q4 Weeks
n=30 Participants
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
n=31 Participants
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B)
Baseline
|
6.341 Units on a Scale
Standard Deviation 0.9034
|
5.919 Units on a Scale
Standard Deviation 0.9676
|
5.908 Units on a Scale
Standard Deviation 0.7332
|
5.755 Units on a Scale
Standard Deviation 0.9706
|
6.190 Units on a Scale
Standard Deviation 0.6829
|
6.051 Units on a Scale
Standard Deviation 0.8791
|
5.688 Units on a Scale
Standard Deviation 0.9529
|
|
Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B)
Change at Week 12
|
-0.619 Units on a Scale
Standard Deviation 0.8541
|
-2.075 Units on a Scale
Standard Deviation 0.7979
|
-1.073 Units on a Scale
Standard Deviation 0.9766
|
-2.248 Units on a Scale
Standard Deviation 1.2050
|
-2.011 Units on a Scale
Standard Deviation 0.8843
|
-2.198 Units on a Scale
Standard Deviation 0.8550
|
-1.964 Units on a Scale
Standard Deviation 0.9532
|
SECONDARY outcome
Timeframe: Week 12Population: Population analyzed included all randomized participants in Part A (excluding a site based on sponsor audit for data integrity). Here 'N'(number of participants analyzed) signifies participants who were evaluable for this outcome measure.
An ACR 50 response is defined as \>= 50% improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and \>= 50% improvement in 3 of the following 5 assessments: Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \[0 = very well to 10 = very poor\]), Physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, \[0=no arthritis activity to 10=extremely active arthritis\]), Participant's assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP.
Outcome measures
| Measure |
Part B: Placebo
n=17 Participants
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
|
Part B: Sirukumab 100 mg q2 Weeks
n=14 Participants
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
|
Part B: Sirukumab 100 mg q4 Weeks
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 50 mg q4 Weeks
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 50 mg q4 Weeks
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A)
|
5.9 Percentage of Participants
|
28.6 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Day 2, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 10, Week 10 Day 4, Week 10 Day 7, Week 12, Week 14, Week 18, Week 22, Week 24, and Week 38Population: Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part A (excluding a site based on sponsor audit for data integrity). Here 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure whereas 'n' signifies participants evaluable at specific time points, for each arm, respectively.
Sirukumab Concentrations in serum were measured.
Outcome measures
| Measure |
Part B: Placebo
n=17 Participants
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
|
Part B: Sirukumab 100 mg q2 Weeks
n=14 Participants
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
|
Part B: Sirukumab 100 mg q4 Weeks
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 50 mg q4 Weeks
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 50 mg q4 Weeks
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
|---|---|---|---|---|---|---|---|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Week 0
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below lower limit of quantification (LLOQ) (0.0977 microgram per milliliter).
|
0.01 Microgram per milliliter
Standard Deviation 0.030
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Day 2
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
3.73 Microgram per milliliter
Standard Deviation 2.581
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Day 5
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
7.40 Microgram per milliliter
Standard Deviation 3.402
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Day 8
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
6.01 Microgram per milliliter
Standard Deviation 2.861
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Day 11
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
5.42 Microgram per milliliter
Standard Deviation 1.866
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Week 2
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
4.78 Microgram per milliliter
Standard Deviation 1.549
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Week 4
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
8.83 Microgram per milliliter
Standard Deviation 3.251
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Week 6
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
10.49 Microgram per milliliter
Standard Deviation 3.327
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Week 8
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
12.36 Microgram per milliliter
Standard Deviation 3.133
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Week 10
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
13.49 Microgram per milliliter
Standard Deviation 3.670
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Week 10 Day 4
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
19.07 Microgram per milliliter
Standard Deviation 4.630
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Week 10 Day 7
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
18.71 Microgram per milliliter
Standard Deviation 4.111
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Week 12
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
14.31 Microgram per milliliter
Standard Deviation 3.438
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Week 14
|
4.78 Microgram per milliliter
Standard Deviation 1.779
|
7.07 Microgram per milliliter
Standard Deviation 2.544
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Week 18
|
8.52 Microgram per milliliter
Standard Deviation 4.338
|
2.74 Microgram per milliliter
Standard Deviation 1.737
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Week 22
|
10.79 Microgram per milliliter
Standard Deviation 5.830
|
1.18 Microgram per milliliter
Standard Deviation 0.816
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Week 24
|
11.37 Microgram per milliliter
Standard Deviation 6.177
|
0.88 Microgram per milliliter
Standard Deviation 0.599
|
—
|
—
|
—
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part A)
Week 38
|
0.41 Microgram per milliliter
Standard Deviation 0.525
|
0.02 Microgram per milliliter
Standard Deviation 0.051
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 24 Day4, Week 24 Day7, Week 26, Week 28, Week 30, Week 34 and Week 38Population: Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure whereas 'n' signifies participants who were evaluable at specific time points, for each arm, respectively.
Sirukumab Concentrations in serum were measured.
Outcome measures
| Measure |
Part B: Placebo
n=26 Participants
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
|
Part B: Sirukumab 100 mg q2 Weeks
n=30 Participants
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
|
Part B: Sirukumab 100 mg q4 Weeks
n=30 Participants
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 50 mg q4 Weeks
n=30 Participants
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
n=31 Participants
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 50 mg q4 Weeks
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
|---|---|---|---|---|---|---|---|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 0
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
0.03 Microgram per milliliter
Standard Deviation 0.087
|
0.00 Microgram per milliliter
Standard Deviation 0.000
|
0.02 Microgram per milliliter
Standard Deviation 0.076
|
0.01 Microgram per milliliter
Standard Deviation 0.048
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Day 5
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
6.75 Microgram per milliliter
Standard Deviation 3.212
|
6.21 Microgram per milliliter
Standard Deviation 2.933
|
2.66 Microgram per milliliter
Standard Deviation 1.447
|
1.59 Microgram per milliliter
Standard Deviation 0.808
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Day 8
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
5.67 Microgram per milliliter
Standard Deviation 2.398
|
5.85 Microgram per milliliter
Standard Deviation 2.774
|
2.61 Microgram per milliliter
Standard Deviation 1.339
|
1.49 Microgram per milliliter
Standard Deviation 0.556
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Day 11
|
0.02 Microgram per milliliter
Standard Deviation 0.063
|
4.50 Microgram per milliliter
Standard Deviation 2.307
|
4.68 Microgram per milliliter
Standard Deviation 2.539
|
2.54 Microgram per milliliter
Standard Deviation 1.233
|
1.26 Microgram per milliliter
Standard Deviation 0.516
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 2
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
4.30 Microgram per milliliter
Standard Deviation 2.265
|
3.81 Microgram per milliliter
Standard Deviation 1.934
|
1.97 Microgram per milliliter
Standard Deviation 0.916
|
1.16 Microgram per milliliter
Standard Deviation 0.426
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 4
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
7.16 Microgram per milliliter
Standard Deviation 3.290
|
2.02 Microgram per milliliter
Standard Deviation 1.073
|
0.97 Microgram per milliliter
Standard Deviation 0.470
|
0.85 Microgram per milliliter
Standard Deviation 1.167
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 8
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
10.54 Microgram per milliliter
Standard Deviation 5.008
|
3.08 Microgram per milliliter
Standard Deviation 1.806
|
1.45 Microgram per milliliter
Standard Deviation 0.764
|
0.99 Microgram per milliliter
Standard Deviation 0.560
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 12
|
NA Microgram per milliliter
Standard Deviation NA
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
|
11.63 Microgram per milliliter
Standard Deviation 5.232
|
3.10 Microgram per milliliter
Standard Deviation 1.633
|
1.79 Microgram per milliliter
Standard Deviation 0.836
|
0.99 Microgram per milliliter
Standard Deviation 0.478
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 16
|
6.84 Microgram per milliliter
Standard Deviation 2.270
|
9.96 Microgram per milliliter
Standard Deviation 5.107
|
3.51 Microgram per milliliter
Standard Deviation 2.545
|
2.03 Microgram per milliliter
Standard Deviation 1.366
|
0.98 Microgram per milliliter
Standard Deviation 0.425
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 20
|
9.94 Microgram per milliliter
Standard Deviation 3.646
|
10.29 Microgram per milliliter
Standard Deviation 4.951
|
3.92 Microgram per milliliter
Standard Deviation 2.665
|
1.80 Microgram per milliliter
Standard Deviation 1.030
|
1.03 Microgram per milliliter
Standard Deviation 0.496
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 24
|
11.04 Microgram per milliliter
Standard Deviation 4.607
|
10.73 Microgram per milliliter
Standard Deviation 5.182
|
3.80 Microgram per milliliter
Standard Deviation 2.815
|
1.89 Microgram per milliliter
Standard Deviation 1.042
|
1.04 Microgram per milliliter
Standard Deviation 0.491
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 24 Day 4
|
16.46 Microgram per milliliter
Standard Deviation 6.826
|
17.34 Microgram per milliliter
Standard Deviation 9.046
|
9.06 Microgram per milliliter
Standard Deviation 5.632
|
4.42 Microgram per milliliter
Standard Deviation 1.293
|
3.36 Microgram per milliliter
Standard Deviation 1.578
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 24 Day 7
|
15.14 Microgram per milliliter
Standard Deviation 5.991
|
15.01 Microgram per milliliter
Standard Deviation 7.853
|
9.58 Microgram per milliliter
Standard Deviation 5.721
|
4.52 Microgram per milliliter
Standard Deviation 1.719
|
2.80 Microgram per milliliter
Standard Deviation 1.580
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 26
|
10.97 Microgram per milliliter
Standard Deviation 4.565
|
10.09 Microgram per milliliter
Standard Deviation 6.808
|
6.49 Microgram per milliliter
Standard Deviation 5.401
|
3.72 Microgram per milliliter
Standard Deviation 1.434
|
1.91 Microgram per milliliter
Standard Deviation 1.009
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 28
|
6.93 Microgram per milliliter
Standard Deviation 3.378
|
6.69 Microgram per milliliter
Standard Deviation 4.329
|
4.15 Microgram per milliliter
Standard Deviation 2.830
|
1.84 Microgram per milliliter
Standard Deviation 0.764
|
1.06 Microgram per milliliter
Standard Deviation 0.539
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 30
|
4.49 Microgram per milliliter
Standard Deviation 2.708
|
4.06 Microgram per milliliter
Standard Deviation 2.341
|
2.42 Microgram per milliliter
Standard Deviation 1.931
|
1.07 Microgram per milliliter
Standard Deviation 0.529
|
0.52 Microgram per milliliter
Standard Deviation 0.335
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 34
|
1.88 Microgram per milliliter
Standard Deviation 1.451
|
1.92 Microgram per milliliter
Standard Deviation 1.403
|
0.94 Microgram per milliliter
Standard Deviation 0.948
|
0.39 Microgram per milliliter
Standard Deviation 0.396
|
0.10 Microgram per milliliter
Standard Deviation 0.138
|
—
|
—
|
|
Serum Sirukumab Concentrations Through Week 38 (Part B)
Week 38
|
0.71 Microgram per milliliter
Standard Deviation 0.756
|
0.72 Microgram per milliliter
Standard Deviation 0.704
|
0.29 Microgram per milliliter
Standard Deviation 0.382
|
0.08 Microgram per milliliter
Standard Deviation 0.114
|
0.01 Microgram per milliliter
Standard Deviation 0.037
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Population analyzed included randomized participants in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Serum CRP is a marker of systemic inflammation. A negative change from baseline in CRP represents improvement.
Outcome measures
| Measure |
Part B: Placebo
n=30 Participants
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
|
Part B: Sirukumab 100 mg q2 Weeks
n=30 Participants
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
|
Part B: Sirukumab 100 mg q4 Weeks
n=30 Participants
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 50 mg q4 Weeks
n=30 Participants
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
n=31 Participants
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 50 mg q4 Weeks
n=17 Participants
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
Part B: Sirukumab 25 mg q4 Weeks
n=14 Participants
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
|
|---|---|---|---|---|---|---|---|
|
Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B)
|
-49.31 Percent change
Standard Deviation 246.040
|
81.46 Percent change
Standard Deviation 25.000
|
88.53 Percent change
Standard Deviation 12.675
|
85.42 Percent change
Standard Deviation 18.242
|
81.22 Percent change
Standard Deviation 24.484
|
19.97 Percent change
Standard Deviation 41.232
|
91.19 Percent change
Standard Deviation 4.812
|
Adverse Events
Part A - Placebo (Wk 0-Wk 12)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part A - Placebo Then Sirukumab (Wk 12 to End of Study)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Part A - Sirukumab (Wk 0-Wk 12)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Part A - Sirukumab Then Placebo (Wk 12 to End of Study)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part B - Placebo (Wk 0-Wk 12)
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Part B - Placebo Then Sirukumab 100 mg q2 Weeks
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Part B - Sirukumab 100mg q2w
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Part B - Sirukumab 100mg q4w
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Part B - Sirukumab 50mg q4w
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Part B - Sirukumab 25mg q4w
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A - Placebo (Wk 0-Wk 12)
n=19 participants at risk
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks
|
Part A - Placebo Then Sirukumab (Wk 12 to End of Study)
n=18 participants at risk
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
|
Part A - Sirukumab (Wk 0-Wk 12)
n=17 participants at risk
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10.
|
Part A - Sirukumab Then Placebo (Wk 12 to End of Study)
n=16 participants at risk
Participants received placebo at Weeks 12 and q2w through Week 22.
|
Part B - Placebo (Wk 0-Wk 12)
n=30 participants at risk
Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks.
|
Part B - Placebo Then Sirukumab 100 mg q2 Weeks
n=26 participants at risk
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24.
|
Part B - Sirukumab 100mg q2w
n=30 participants at risk
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
|
Part B - Sirukumab 100mg q4w
n=30 participants at risk
Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
|
Part B - Sirukumab 50mg q4w
n=30 participants at risk
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
|
Part B - Sirukumab 25mg q4w
n=31 participants at risk
Participants received 25 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Blindness
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Arthritis Bacterial
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Bursitis Infective
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Cellulitis Staphylococcal
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Pelvic Inflammatory Disease
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Investigations
Transaminases Increased
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrosarcoma
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Nervous system disorders
Facial Paresis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Nervous system disorders
Intracranial Aneurysm
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Nervous system disorders
Vertebral Artery Occlusion
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
Other adverse events
| Measure |
Part A - Placebo (Wk 0-Wk 12)
n=19 participants at risk
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks
|
Part A - Placebo Then Sirukumab (Wk 12 to End of Study)
n=18 participants at risk
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
|
Part A - Sirukumab (Wk 0-Wk 12)
n=17 participants at risk
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10.
|
Part A - Sirukumab Then Placebo (Wk 12 to End of Study)
n=16 participants at risk
Participants received placebo at Weeks 12 and q2w through Week 22.
|
Part B - Placebo (Wk 0-Wk 12)
n=30 participants at risk
Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks.
|
Part B - Placebo Then Sirukumab 100 mg q2 Weeks
n=26 participants at risk
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24.
|
Part B - Sirukumab 100mg q2w
n=30 participants at risk
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
|
Part B - Sirukumab 100mg q4w
n=30 participants at risk
Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
|
Part B - Sirukumab 50mg q4w
n=30 participants at risk
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
|
Part B - Sirukumab 25mg q4w
n=31 participants at risk
Participants received 25 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic Diathesis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
11.5%
3/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
13.3%
4/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
13.3%
4/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
16.7%
5/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
9.7%
3/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
11.1%
2/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Cardiac disorders
Bundle Branch Block Left
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Eye disorders
Eye Pain
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Eye disorders
Uveitis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Eye disorders
Vision Blurred
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
9.7%
3/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
17.6%
3/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.5%
2/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
General disorders
Fatigue
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
General disorders
Injection Site Erythema
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
22.2%
4/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
35.3%
6/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
7.7%
2/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
10.0%
3/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
13.3%
4/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
19.4%
6/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
General disorders
Injection Site Pain
|
5.3%
1/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
23.5%
4/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
General disorders
Injection Site Pruritus
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
11.8%
2/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
General disorders
Injection Site Rash
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
General disorders
Injection Site Swelling
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
11.8%
2/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
General disorders
Injection Site Urticaria
|
5.3%
1/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
General disorders
Injection Site Warmth
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Acute Tonsillitis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Bronchitis
|
10.5%
2/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
11.1%
2/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
11.8%
2/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
16.7%
5/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.5%
2/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.5%
2/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Staphylococcal Skin Infection
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.5%
2/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
10.0%
3/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
10.0%
3/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.5%
2/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Injury, poisoning and procedural complications
Synovial Rupture
|
5.3%
1/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
22.2%
4/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
11.8%
2/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
13.3%
4/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
23.3%
7/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
33.3%
10/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
19.4%
6/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
11.8%
2/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
10.0%
3/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
13.3%
4/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
20.0%
6/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
9.7%
3/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Investigations
Blood Cholesterol Increased
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
10.0%
3/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Investigations
Blood Glucose Increased
|
5.3%
1/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Investigations
Blood Insulin Increased
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
10.0%
3/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
12.5%
2/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Investigations
Haemoglobin Decreased
|
5.3%
1/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Investigations
Insulin Resistance Test
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
10.0%
3/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Investigations
Intraocular Pressure Increased
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Investigations
Transaminases Increased
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.5%
2/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.5%
2/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.3%
1/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
29.4%
5/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
12.5%
2/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
16.7%
5/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
12.9%
4/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.5%
2/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.3%
1/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
10.5%
2/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
12.5%
2/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
10.0%
3/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Musculoskeletal and connective tissue disorders
Tendon Pain
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
10.0%
3/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.8%
1/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.5%
2/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Nervous system disorders
Migraine
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.6%
1/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
7.7%
2/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.3%
1/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
5.9%
1/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
3.2%
1/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Vascular disorders
Haematoma
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.2%
1/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
9.7%
3/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/19 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/18 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/17 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/16 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/26 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
6.7%
2/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/30 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
0.00%
0/31 • Screening up to Week 38
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
|
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