Trial Outcomes & Findings for A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis (NCT NCT02019472)
NCT ID: NCT02019472
Last Updated: 2017-10-26
Results Overview
The Disease Activity Index Score 28 using ESR \[DAS28 (ESR)\] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient's Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of "0-10", with the minimum score= 0 (best) to maximum score= 10 (worst).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
559 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2017-10-26
Participant Flow
A total of 559 participants were randomized and treated. All participants received at least one administration of study treatment.
Participant milestones
| Measure |
Adalimumab 40 mg
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
|
Sirukumab 50 mg
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
|
Sirukumab 100 mg
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
|
|---|---|---|---|
|
Overall Study
STARTED
|
186
|
186
|
187
|
|
Overall Study
COMPLETED
|
149
|
134
|
145
|
|
Overall Study
NOT COMPLETED
|
37
|
52
|
42
|
Reasons for withdrawal
| Measure |
Adalimumab 40 mg
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
|
Sirukumab 50 mg
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
|
Sirukumab 100 mg
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
14
|
23
|
17
|
|
Overall Study
Death
|
0
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
7
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
2
|
0
|
|
Overall Study
Pregnancy
|
1
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
11
|
10
|
11
|
|
Overall Study
Other
|
3
|
8
|
6
|
Baseline Characteristics
A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Adalimumab 40 mg
n=186 Participants
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
|
Sirukumab 50 mg
n=186 Participants
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
|
Sirukumab 100 mg
n=187 Participants
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
|
Total
n=559 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
163 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
486 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 12.15 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 12.46 • n=7 Participants
|
49.8 years
STANDARD_DEVIATION 12.31 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 12.36 • n=4 Participants
|
|
Sex: Female, Male
Female
|
156 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
467 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Chile
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Colombia
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
1 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Lithuania
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
9 participants
n=5 Participants
|
36 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Moldova
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
21 participants
n=5 Participants
|
17 participants
n=7 Participants
|
20 participants
n=5 Participants
|
58 participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
33 participants
n=5 Participants
|
92 participants
n=4 Participants
|
|
Region of Enrollment
Serbia
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
26 participants
n=5 Participants
|
65 participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
7 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
42 participants
n=5 Participants
|
37 participants
n=7 Participants
|
39 participants
n=5 Participants
|
118 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
32 participants
n=7 Participants
|
31 participants
n=5 Participants
|
88 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent. Participants with missing DAS28 (ESR) at baseline were excluded from the analysis.
The Disease Activity Index Score 28 using ESR \[DAS28 (ESR)\] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient's Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of "0-10", with the minimum score= 0 (best) to maximum score= 10 (worst).
Outcome measures
| Measure |
Adalimumab 40 mg
n=186 Participants
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
|
Sirukumab 50 mg
n=185 Participants
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
|
Sirukumab 100 mg
n=185 Participants
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
|
|---|---|---|---|
|
Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24
Baseline
|
6.89 units on a scale
Standard Deviation 0.851
|
6.90 units on a scale
Standard Deviation 0.881
|
6.91 units on a scale
Standard Deviation 0.863
|
|
Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24
Change from Baseline at Week 24
|
-2.19 units on a scale
Standard Deviation 1.437
|
-2.58 units on a scale
Standard Deviation 1.524
|
-2.96 units on a scale
Standard Deviation 1.58
|
PRIMARY outcome
Timeframe: Week 24Population: Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.
The ACR 50 Response is defined as greater than or equal to (\>=) 50 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>= 50% improvement in 3 of following 5 assessments: subject's assessment of pain using Visual Analog Scale (VAS) (0-10 millimeter \[mm\], 0 mm=no pain and 10 mm=worst possible pain), subject's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, \[0 mm=no pain to 100 mm=worst possible pain\]), 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 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 |
Adalimumab 40 mg
n=186 Participants
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
|
Sirukumab 50 mg
n=186 Participants
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
|
Sirukumab 100 mg
n=187 Participants
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24
|
31.7 Percentage of participants
|
26.9 Percentage of participants
|
35.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.
The Disease Activity Index Score 28 using ESR \[DAS28 (ESR)\] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient's Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of "0-10", with the minimum score= 0 (best) to maximum score= 10 (worst). The DAS28 (ESR) remission is defined as a DAS28 (ESR) value of less than 2.6 at a visit.
Outcome measures
| Measure |
Adalimumab 40 mg
n=186 Participants
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
|
Sirukumab 50 mg
n=186 Participants
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
|
Sirukumab 100 mg
n=187 Participants
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
|
|---|---|---|---|
|
Percentage of Participants With Disease Activity Index Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Remission at Week 24
|
7.5 Percentage of participants
|
12.9 Percentage of participants
|
20.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.
The ACR 20 Response is defined as \>= 20% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=20% improvement in 3 of following 5 assessments: subject's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), subject's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, \[0 mm=no pain to 100 mm=worst possible pain\]), physician's global assessment of disease activity using VAS, subject's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum CRP.
Outcome measures
| Measure |
Adalimumab 40 mg
n=186 Participants
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
|
Sirukumab 50 mg
n=186 Participants
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
|
Sirukumab 100 mg
n=187 Participants
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24
|
56.5 Percentage of participants
|
53.8 Percentage of participants
|
58.8 Percentage of participants
|
Adverse Events
Adalimumab 40 mg q2w Only
Serious events: 15 serious events
Other events: 71 other events
Deaths: 0 deaths
Adalimumab 40 mg q2w Then 40 mg q1w
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Adalimumab 40 mg
Serious events: 16 serious events
Other events: 74 other events
Deaths: 0 deaths
Sirukumab 50 mg q4w Only
Serious events: 23 serious events
Other events: 79 other events
Deaths: 0 deaths
Sirukumab 50 mg q4w Then 100 mg q2w
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Sirukumab 50 mg
Serious events: 29 serious events
Other events: 92 other events
Deaths: 0 deaths
Sirukumab 100 mg
Serious events: 22 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab 40 mg q2w Only
n=173 participants at risk
Participants received 40 mg of adalimumab subcutaneously q2w for 52 weeks.
|
Adalimumab 40 mg q2w Then 40 mg q1w
n=13 participants at risk
Participants received 40 mg adalimumab subcutaneously q2w until Week 16 and received 40 mg adalimumab subcutaneously weekly (q1w) (due to EE) through Week 52.
|
Adalimumab 40 mg
n=186 participants at risk
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
|
Sirukumab 50 mg q4w Only
n=160 participants at risk
Participants received 50 mg of sirukumab subcutaneously every four weeks (q4w) for 52 weeks.
|
Sirukumab 50 mg q4w Then 100 mg q2w
n=26 participants at risk
Participants received 50 mg sirukumab until Week 16 and received 100 mg sirukumab subcutaneously q4w (due to EE or inadvertently) through Week 52.
|
Sirukumab 50 mg
n=186 participants at risk
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
|
Sirukumab 100 mg
n=187 participants at risk
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
1.2%
2/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
1.1%
2/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
3.8%
1/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
7.7%
1/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
3.8%
1/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
General disorders
Peripheral swelling
|
1.2%
2/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
1.1%
2/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Bursitis infective
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
1.2%
2/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
1.1%
2/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Erysipelas
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
3.8%
1/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Herpes ophthalmic
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
1.2%
2/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
1.1%
2/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Tongue abscess
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
3.8%
1/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
3.8%
1/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
3.8%
1/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gliomatosis cerebri
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
3.8%
1/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Nervous system disorders
Neuralgia
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
3.8%
1/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.58%
1/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.53%
1/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.62%
1/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.54%
1/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
Other adverse events
| Measure |
Adalimumab 40 mg q2w Only
n=173 participants at risk
Participants received 40 mg of adalimumab subcutaneously q2w for 52 weeks.
|
Adalimumab 40 mg q2w Then 40 mg q1w
n=13 participants at risk
Participants received 40 mg adalimumab subcutaneously q2w until Week 16 and received 40 mg adalimumab subcutaneously weekly (q1w) (due to EE) through Week 52.
|
Adalimumab 40 mg
n=186 participants at risk
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
|
Sirukumab 50 mg q4w Only
n=160 participants at risk
Participants received 50 mg of sirukumab subcutaneously every four weeks (q4w) for 52 weeks.
|
Sirukumab 50 mg q4w Then 100 mg q2w
n=26 participants at risk
Participants received 50 mg sirukumab until Week 16 and received 100 mg sirukumab subcutaneously q4w (due to EE or inadvertently) through Week 52.
|
Sirukumab 50 mg
n=186 participants at risk
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
|
Sirukumab 100 mg
n=187 participants at risk
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
2.3%
4/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
2.2%
4/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
10.0%
16/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
3.8%
1/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
9.1%
17/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.9%
11/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
General disorders
Injection site erythema
|
7.5%
13/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
7.0%
13/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
9.4%
15/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
7.7%
2/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
9.1%
17/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
17.6%
33/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
General disorders
Injection site pruritus
|
4.6%
8/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
4.3%
8/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
3.8%
6/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
3.2%
6/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
9.1%
17/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
General disorders
Injection site swelling
|
2.3%
4/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
2.2%
4/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
1.9%
3/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
3.8%
1/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
2.2%
4/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.9%
11/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Bronchitis
|
2.3%
4/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
2.2%
4/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.0%
8/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
7.7%
2/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.4%
10/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
4.3%
8/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
9.2%
16/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
8.6%
16/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.6%
9/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
3.8%
1/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.4%
10/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
4.8%
9/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
10/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.4%
10/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.0%
8/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
7.7%
2/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.4%
10/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
4.8%
9/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
6.9%
12/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
6.5%
12/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
11.2%
18/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
11.5%
3/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
11.3%
21/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
12.8%
24/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
6.4%
11/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.9%
11/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.6%
9/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
15.4%
4/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
7.0%
13/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
10.7%
20/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
9.8%
17/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
0.00%
0/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
9.1%
17/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
10.6%
17/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
11.5%
3/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
10.8%
20/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
8.0%
15/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Nervous system disorders
Headache
|
5.2%
9/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
15.4%
2/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.9%
11/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
6.2%
10/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
3.8%
1/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.9%
11/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
7.0%
13/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
|
Vascular disorders
Hypertension
|
5.2%
9/173 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
7.7%
1/13 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.4%
10/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
5.0%
8/160 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
15.4%
4/26 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
6.5%
12/186 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
4.3%
8/187 • Screening, up to Week 68
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
|
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