Trial Outcomes & Findings for A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy (NCT NCT00361335)
NCT ID: NCT00361335
Last Updated: 2014-07-29
Results Overview
An ACR 50 response is defined as a greater than or equal to 50 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b. Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
643 participants
Primary outcome timeframe
Week 0 to Week 14
Results posted on
2014-07-29
Participant Flow
The study was conducted at 86 investigational sites. The study population included 643 randomized participants from 15 countries.
A total of 643 participants were randomized in the IV Period (Main Study). A total of 508 participants were randomized in the SC Period (Extension Study); participation in the SC Period was optional.
Participant milestones
| Measure |
2mg/kg Golimumab+ MTX
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
|
2mg/kg Golimumab Only
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
|
4mg/kg Golimumab + MTX
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
|
4mg/kg Golimumab Only
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
|
IV Placebo + MTX
Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
|
EE/DRA -> 2mg/kg Golimumab + MTX
At Week 16 and Week 24 participants entered early escape (EE) and dose regimen adjustment (DRA), respectively, depending on joint assessment results and received IV infusions of 2mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
|
EE/DRA -> 4mg/kg Golimumab + MTX
At Week 16 and Week 24 participants entered EE and DRA, respectively, depending on joint assessment results and received IV infusions of 4mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
|
|---|---|---|---|---|---|---|---|
|
IV Period: Baseline to E0
STARTED
|
129
|
128
|
128
|
129
|
129
|
0
|
0
|
|
IV Period: Baseline to E0
COMPLETED
|
109
|
99
|
107
|
102
|
105
|
0
|
0
|
|
IV Period: Baseline to E0
NOT COMPLETED
|
20
|
29
|
21
|
27
|
24
|
0
|
0
|
|
SC Period: Week E0 to Week E24
STARTED
|
82
|
59
|
104
|
63
|
3
|
24
|
173
|
|
SC Period: Week E0 to Week E24
COMPLETED
|
80
|
56
|
99
|
59
|
3
|
23
|
164
|
|
SC Period: Week E0 to Week E24
NOT COMPLETED
|
2
|
3
|
5
|
4
|
0
|
1
|
9
|
Reasons for withdrawal
| Measure |
2mg/kg Golimumab+ MTX
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
|
2mg/kg Golimumab Only
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
|
4mg/kg Golimumab + MTX
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
|
4mg/kg Golimumab Only
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
|
IV Placebo + MTX
Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
|
EE/DRA -> 2mg/kg Golimumab + MTX
At Week 16 and Week 24 participants entered early escape (EE) and dose regimen adjustment (DRA), respectively, depending on joint assessment results and received IV infusions of 2mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
|
EE/DRA -> 4mg/kg Golimumab + MTX
At Week 16 and Week 24 participants entered EE and DRA, respectively, depending on joint assessment results and received IV infusions of 4mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
|
|---|---|---|---|---|---|---|---|
|
IV Period: Baseline to E0
Adverse Event
|
9
|
4
|
5
|
9
|
8
|
0
|
0
|
|
IV Period: Baseline to E0
Lost to Follow-up
|
1
|
0
|
0
|
2
|
2
|
0
|
0
|
|
IV Period: Baseline to E0
Death
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
|
IV Period: Baseline to E0
Discontinued oral study agent
|
2
|
1
|
1
|
1
|
2
|
0
|
0
|
|
IV Period: Baseline to E0
Protocol-prohibited medications
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
IV Period: Baseline to E0
Worsening of RA
|
0
|
5
|
1
|
4
|
2
|
0
|
0
|
|
IV Period: Baseline to E0
Other
|
2
|
9
|
9
|
3
|
2
|
0
|
0
|
|
IV Period: Baseline to E0
Lack of Efficacy
|
5
|
9
|
3
|
7
|
8
|
0
|
0
|
|
SC Period: Week E0 to Week E24
Adverse Event
|
0
|
2
|
1
|
2
|
0
|
0
|
2
|
|
SC Period: Week E0 to Week E24
Lost to Follow-up
|
1
|
0
|
1
|
0
|
0
|
0
|
1
|
|
SC Period: Week E0 to Week E24
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
SC Period: Week E0 to Week E24
Worsening of RA
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
|
SC Period: Week E0 to Week E24
Other
|
1
|
0
|
0
|
1
|
0
|
1
|
2
|
|
SC Period: Week E0 to Week E24
Lack of Efficacy
|
0
|
0
|
2
|
0
|
0
|
0
|
3
|
Baseline Characteristics
A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Baseline characteristics by cohort
| Measure |
2mg/kg Golimumab+ MTX
n=129 Participants
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
|
2mg/kg Golimumab Only
n=128 Participants
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
|
4mg/kg Golimumab + MTX
n=128 Participants
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
|
4mg/kg Golimumab Only
n=129 Participants
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
|
IV Placebo + MTX
n=129 Participants
Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
|
Total
n=643 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 11.10 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 11.86 • n=7 Participants
|
49.6 years
STANDARD_DEVIATION 10.96 • n=5 Participants
|
48.4 years
STANDARD_DEVIATION 12.66 • n=4 Participants
|
50.2 years
STANDARD_DEVIATION 11.28 • n=21 Participants
|
49.4 years
STANDARD_DEVIATION 11.65 • n=10 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
517 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
126 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Week 0 to Week 14Population: Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.
An ACR 50 response is defined as a greater than or equal to 50 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b. Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).
Outcome measures
| Measure |
Group I: 2mg/kg Golimumab+ MTX
n=129 Participants
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
|
Group II: 2mg/kg Golimumab Only
n=128 Participants
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
|
Group III: 4mg/kg Golimumab + MTX
n=128 Participants
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
|
Group IV: 4mg/kg Golimumab Only
n=129 Participants
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
|
Group V: IV Placebo + MTX
n=129 Participants
Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
|
Group VI: Combined Groups I and III
n=257 Participants
Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
|
Group VII: Combined Groups II and IV
n=257 Participants
Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14
|
28 Participants
|
16 Participants
|
27 Participants
|
25 Participants
|
17 Participants
|
55 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 24ACR 50 response is an improvement of greater than or equal to 50 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity (based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities) and CRP blood test to measure inflammation).
Outcome measures
| Measure |
Group I: 2mg/kg Golimumab+ MTX
n=129 Participants
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
|
Group II: 2mg/kg Golimumab Only
n=128 Participants
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
|
Group III: 4mg/kg Golimumab + MTX
n=128 Participants
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
|
Group IV: 4mg/kg Golimumab Only
n=129 Participants
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
|
Group V: IV Placebo + MTX
n=129 Participants
Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
|
Group VI: Combined Groups I and III
n=257 Participants
Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
|
Group VII: Combined Groups II and IV
n=257 Participants
Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24
|
24 Participants
|
11 Participants
|
32 Participants
|
15 Participants
|
12 Participants
|
56 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 14Population: Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.
ACR 20 response is an improvement of greater than or equal to 20 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity \[based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities\] and CRP blood test to measure inflammation).
Outcome measures
| Measure |
Group I: 2mg/kg Golimumab+ MTX
n=129 Participants
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
|
Group II: 2mg/kg Golimumab Only
n=128 Participants
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
|
Group III: 4mg/kg Golimumab + MTX
n=128 Participants
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
|
Group IV: 4mg/kg Golimumab Only
n=129 Participants
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
|
Group V: IV Placebo + MTX
n=129 Participants
Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
|
Group VI: Combined Groups I and III
n=257 Participants
Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
|
Group VII: Combined Groups II and IV
n=257 Participants
Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14
|
71 Participants
|
51 Participants
|
66 Participants
|
62 Participants
|
36 Participants
|
137 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 14Population: Intent to treat. Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing components were imputed by the median component value of all patients in the same stratum unless all components are missing in which case considered non-responders.
DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessment of disease activity. Values range from 0 (best) to 10 (worst). A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A "Good" response is defined as a patient with a DAS28 score of \<= 3.2 at Week 14 with improvement from Baseline in DAS28 score of \> 1.2. A "Moderate" response is defined as a patient with DAS28 score of \>3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of \>1.2 or a DAS28 score of \<= 5.1 and improvement from baseline in DAS28 score of \>0.6 to 1.2
Outcome measures
| Measure |
Group I: 2mg/kg Golimumab+ MTX
n=129 Participants
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
|
Group II: 2mg/kg Golimumab Only
n=128 Participants
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
|
Group III: 4mg/kg Golimumab + MTX
n=128 Participants
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
|
Group IV: 4mg/kg Golimumab Only
n=129 Participants
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
|
Group V: IV Placebo + MTX
n=129 Participants
Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
|
Group VI: Combined Groups I and III
n=257 Participants
Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
|
Group VII: Combined Groups II and IV
n=257 Participants
Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14
|
89 Participants
|
80 Participants
|
94 Participants
|
83 Participants
|
57 Participants
|
183 Participants
|
163 Participants
|
SECONDARY outcome
Timeframe: Weeks 0 to Week 14Population: Intent to treat (ITT). Missing components were imputed by the median component value of all patients in the same Stratum at baseline, and last observation carried forward (LOCF) at Week 14
The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems, usual role activities due to physical health problems, bodily pain, usual role activities due to personal or emotional problems, social functioning due to physical or mental health problems, general mental health (psychological distress and well-being), vitality and general health perception. The values are 100=best to 0=worst.
Outcome measures
| Measure |
Group I: 2mg/kg Golimumab+ MTX
n=129 Participants
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
|
Group II: 2mg/kg Golimumab Only
n=128 Participants
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
|
Group III: 4mg/kg Golimumab + MTX
n=128 Participants
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
|
Group IV: 4mg/kg Golimumab Only
n=129 Participants
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
|
Group V: IV Placebo + MTX
n=129 Participants
Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
|
Group VI: Combined Groups I and III
n=257 Participants
Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
|
Group VII: Combined Groups II and IV
n=257 Participants
Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
|
|---|---|---|---|---|---|---|---|
|
Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14
|
6.92 Units on a scale
Standard Deviation 9.175
|
4.03 Units on a scale
Standard Deviation 7.462
|
6.76 Units on a scale
Standard Deviation 8.252
|
5.14 Units on a scale
Standard Deviation 9.674
|
4.27 Units on a scale
Standard Deviation 7.216
|
6.84 Units on a scale
Standard Deviation 8.702
|
4.58 Units on a scale
Standard Deviation 8.644
|
Adverse Events
IV Period: 2mg/kg Golimumab+ MTX
Serious events: 25 serious events
Other events: 109 other events
Deaths: 0 deaths
IV Period: 2mg/kg Golimumab Only
Serious events: 17 serious events
Other events: 71 other events
Deaths: 0 deaths
IV Period: 4mg/kg Golimumab + MTX
Serious events: 47 serious events
Other events: 190 other events
Deaths: 0 deaths
IV Period: 4mg/kg Golimumab Only
Serious events: 8 serious events
Other events: 70 other events
Deaths: 0 deaths
IV Period: Placebo + MTX
Serious events: 7 serious events
Other events: 65 other events
Deaths: 0 deaths
SC Period: 50mg Golimumab + MTX
Serious events: 38 serious events
Other events: 94 other events
Deaths: 0 deaths
SC Period: 50mg Golimumab Only
Serious events: 8 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IV Period: 2mg/kg Golimumab+ MTX
n=182 participants at risk
Participants who received 2mg/kg IV golimumab and methotrexate (MTX). Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 2mg/kg IV golimumab and before receiving 4mg/kg IV golimumab
|
IV Period: 2mg/kg Golimumab Only
n=128 participants at risk
Participants who received 2mg/kg IV golimumab only. Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 2mg/kg IV golimumab.
|
IV Period: 4mg/kg Golimumab + MTX
n=336 participants at risk
Participants who received at least one 4 mg/kg IV golimumab dose and MTX. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 4mg/kg IV golimumab.
|
IV Period: 4mg/kg Golimumab Only
n=127 participants at risk
Participants who received at least one 4mg/kg IV golimumab dose. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 4mg/kg IV golimumab.
|
IV Period: Placebo + MTX
n=129 participants at risk
Participants who received IV placebo and MTX only. Follow-up time was counted in this group until the participant started to receive IV golimumab.
|
SC Period: 50mg Golimumab + MTX
n=419 participants at risk
Participants who received 50mg SC golimumab and MTX.
|
SC Period: 50mg Golimumab Only
n=117 participants at risk
Participants who received 50mg golimumab only. Participants must not have received any MTX while receiving 50mg SC golimumab.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
2.3%
3/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.89%
3/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.79%
1/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.2%
5/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.2%
4/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.48%
2/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.79%
1/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.89%
3/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.48%
2/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Appendicitis
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Arthritis bacterial
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.60%
2/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Cervicitis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Eye abcess
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.79%
1/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Infection
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Injury, poisoning and procedural complications
Complicated fracture
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.79%
1/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
1.1%
2/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Cardiac disorders
Angina unstable
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.79%
1/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
2.6%
3/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.60%
2/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.72%
3/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.60%
2/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.48%
2/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Gastrointestinal disorders
Nausea
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.79%
1/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian low malignant potential tumour
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Nervous system disorders
Headache
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Nervous system disorders
Syringomyelia
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Psychiatric disorders
Depression
|
1.1%
2/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Psychiatric disorders
Generalized anxiety disorder
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Reproductive system and breast disorders
Uterine cervical squamous metaplasia
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Vascular disorders
Aortic stenosis
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Eye disorders
Keratitis
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
General disorders
Chest pain
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.79%
1/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Abscess
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.79%
1/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Anogenital warts
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Breast cellulitis
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Lymph node tuberculosis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Septic shock
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.79%
1/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid nodule
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.55%
1/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
General disorders
Death
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.79%
1/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.30%
1/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Gastrointestinal disorders
Appendix disorder
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
General disorders
Oedema
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Intevertebral discitis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Injury, poisoning and procedural complications
Narcotic intoxication
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Musculoskeletal and connective tissue disorders
Atlantoaxial instability
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Nervous system disorders
Cervical cord compression
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.24%
1/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
Other adverse events
| Measure |
IV Period: 2mg/kg Golimumab+ MTX
n=182 participants at risk
Participants who received 2mg/kg IV golimumab and methotrexate (MTX). Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 2mg/kg IV golimumab and before receiving 4mg/kg IV golimumab
|
IV Period: 2mg/kg Golimumab Only
n=128 participants at risk
Participants who received 2mg/kg IV golimumab only. Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 2mg/kg IV golimumab.
|
IV Period: 4mg/kg Golimumab + MTX
n=336 participants at risk
Participants who received at least one 4 mg/kg IV golimumab dose and MTX. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 4mg/kg IV golimumab.
|
IV Period: 4mg/kg Golimumab Only
n=127 participants at risk
Participants who received at least one 4mg/kg IV golimumab dose. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 4mg/kg IV golimumab.
|
IV Period: Placebo + MTX
n=129 participants at risk
Participants who received IV placebo and MTX only. Follow-up time was counted in this group until the participant started to receive IV golimumab.
|
SC Period: 50mg Golimumab + MTX
n=419 participants at risk
Participants who received 50mg SC golimumab and MTX.
|
SC Period: 50mg Golimumab Only
n=117 participants at risk
Participants who received 50mg golimumab only. Participants must not have received any MTX while receiving 50mg SC golimumab.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
12.1%
22/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
10.9%
14/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
12.2%
41/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
12.6%
16/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
9.3%
12/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
7.2%
30/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
8.5%
10/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Bronchitis
|
7.7%
14/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
7.8%
10/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
7.7%
26/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
6.3%
8/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
5.4%
7/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
5.3%
22/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.7%
2/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
13/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
7.0%
9/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.9%
13/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
6.3%
8/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
5.4%
7/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
4.5%
19/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
7.7%
9/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Influenza
|
3.3%
6/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
7.8%
10/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.0%
10/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.9%
5/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.6%
15/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
2.6%
3/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Urinary tract infection
|
4.4%
8/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.9%
5/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
6.2%
21/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
5.5%
7/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.6%
2/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.7%
7/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.4%
4/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
6.6%
12/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
15.6%
20/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
5.7%
19/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
9.4%
12/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
4.7%
6/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
6.9%
29/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
5.1%
6/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.4%
8/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
4.7%
6/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
6.0%
20/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
4.7%
6/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
5.4%
7/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.4%
6/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.2%
15/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.1%
4/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
4.2%
14/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
5.5%
7/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.6%
2/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.6%
15/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.4%
4/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Gastrointestinal disorders
Nausea
|
11.0%
20/182 • Number of events 129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.1%
4/128 • Number of events 128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
10.7%
36/336 • Number of events 128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
5.5%
7/127 • Number of events 129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
7.0%
9/129 • Number of events 129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
2.4%
10/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.6%
12/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
2.3%
3/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
5.1%
17/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.1%
4/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.6%
2/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.4%
6/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
8/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.6%
2/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.3%
11/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.1%
4/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
6.2%
8/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.4%
6/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.7%
2/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Nervous system disorders
Headache
|
9.3%
17/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
6.2%
8/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
7.7%
26/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
6.3%
8/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
10.1%
13/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
4.8%
20/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.7%
2/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.4%
8/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
7.0%
9/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
2.7%
9/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
4.7%
6/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.6%
2/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.2%
5/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.7%
2/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Vascular disorders
Hypertension
|
7.7%
14/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
6.2%
8/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
4.5%
15/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.1%
4/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.9%
5/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.7%
7/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.85%
1/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Investigations
Alanine aminotransferase increased
|
8.2%
15/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
2.3%
3/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
5.7%
19/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
2.4%
3/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
6.2%
8/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
4.3%
18/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
2.6%
3/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Investigations
Aspartate aminotransferase increased
|
3.8%
7/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.78%
1/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.3%
11/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
0.00%
0/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
6.2%
8/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
2.4%
10/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
2.6%
3/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Infections and infestations
Sinusitis
|
6.0%
11/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
2.3%
3/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
7.1%
24/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
5.5%
7/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
4.7%
6/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.6%
15/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
2.6%
3/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.4%
8/182 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
5.5%
7/128 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
5.4%
18/336 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.9%
5/127 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
3.9%
5/129 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.7%
7/419 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
1.7%
2/117 • IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
|
Additional Information
Senior Director Clinical Research
Centocor, Inc.
Phone: 1-800-457-6399
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER