Trial Outcomes & Findings for Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE) (NCT NCT01261793)
NCT ID: NCT01261793
Last Updated: 2020-12-04
Results Overview
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
791 participants
Primary outcome timeframe
At Week 48
Results posted on
2020-12-04
Participant Flow
The study started to enroll patients in December 2010 and concluded in June 2015.
Participant Flow refers to the Randomized Set (RS).
Participant milestones
| Measure |
Placebo Weekly (RS)
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 1200 mg Every Other Week (RS)
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 600 mg Weekly (RS)
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
|
|---|---|---|---|
|
Overall Study
STARTED
|
263
|
262
|
266
|
|
Overall Study
COMPLETED
|
178
|
171
|
184
|
|
Overall Study
NOT COMPLETED
|
85
|
91
|
82
|
Reasons for withdrawal
| Measure |
Placebo Weekly (RS)
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 1200 mg Every Other Week (RS)
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 600 mg Weekly (RS)
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
44
|
37
|
32
|
|
Overall Study
Protocol Violation
|
3
|
5
|
6
|
|
Overall Study
Lost to Follow-up
|
10
|
3
|
7
|
|
Overall Study
Withdrawal by Subject
|
12
|
14
|
14
|
|
Overall Study
Death
|
3
|
1
|
0
|
|
Overall Study
Adverse Event
|
9
|
24
|
19
|
|
Overall Study
Patient non-availability
|
1
|
1
|
1
|
|
Overall Study
Suspected pregnancy
|
1
|
1
|
0
|
|
Overall Study
Patient non-compliance
|
1
|
0
|
1
|
|
Overall Study
Patient pregnant
|
1
|
0
|
0
|
|
Overall Study
Outside the study area
|
0
|
2
|
1
|
|
Overall Study
Lack of efficacy & patient not available
|
0
|
1
|
0
|
|
Overall Study
Patient withdrew after cardiology visit
|
0
|
1
|
0
|
|
Overall Study
Randomization error
|
0
|
1
|
0
|
|
Overall Study
Patient unable to start IV line
|
0
|
0
|
1
|
Baseline Characteristics
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
Baseline characteristics by cohort
| Measure |
Placebo Weekly (SS)
n=263 Participants
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 1200 mg Every Other Week (SS)
n=261 Participants
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 600 mg Weekly (SS)
n=264 Participants
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
|
Total Title
n=788 Participants
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
254 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
765 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
40.8 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
41.0 years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
245 Participants
n=5 Participants
|
247 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
737 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Week 48Population: The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
Outcome measures
| Measure |
Placebo Weekly (FAS)
n=263 Participants
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 1200 mg Every Other Week (FAS)
n=261 Participants
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 600 mg Weekly (FAS)
n=264 Participants
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
|
|---|---|---|---|
|
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
|
33.5 Percentage of responders
|
34.1 Percentage of responders
|
35.2 Percentage of responders
|
SECONDARY outcome
Timeframe: At Week 24Population: The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
Outcome measures
| Measure |
Placebo Weekly (FAS)
n=263 Participants
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 1200 mg Every Other Week (FAS)
n=261 Participants
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 600 mg Weekly (FAS)
n=264 Participants
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
|
|---|---|---|---|
|
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index
|
32.3 Percentage of responders
|
33.0 Percentage of responders
|
43.6 Percentage of responders
|
SECONDARY outcome
Timeframe: At Week 12Population: The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
Outcome measures
| Measure |
Placebo Weekly (FAS)
n=263 Participants
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 1200 mg Every Other Week (FAS)
n=261 Participants
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 600 mg Weekly (FAS)
n=264 Participants
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
|
|---|---|---|---|
|
The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index
|
30.0 Percentage of responders
|
32.2 Percentage of responders
|
40.9 Percentage of responders
|
SECONDARY outcome
Timeframe: At Week 36Population: The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
Outcome measures
| Measure |
Placebo Weekly (FAS)
n=263 Participants
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 1200 mg Every Other Week (FAS)
n=261 Participants
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 600 mg Weekly (FAS)
n=264 Participants
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
|
|---|---|---|---|
|
The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index
|
32.7 Percentage of responders
|
33.0 Percentage of responders
|
36.7 Percentage of responders
|
SECONDARY outcome
Timeframe: At Week 24Population: The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.
Participants were grouped into 4 categories: Dose decreased by \>50%, Dose decreased \>0% to ≤50%, No change in dose and Dose increased or missing data.
Outcome measures
| Measure |
Placebo Weekly (FAS)
n=263 Participants
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 1200 mg Every Other Week (FAS)
n=261 Participants
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 600 mg Weekly (FAS)
n=264 Participants
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
|
|---|---|---|---|
|
Change From Baseline in Daily Corticosteroid Dose at Week 24
Dose decreased by >50%
|
4.6 Percentage of subjects
0
|
10.0 Percentage of subjects
0
|
8.7 Percentage of subjects
0
|
|
Change From Baseline in Daily Corticosteroid Dose at Week 24
Dose decreased >0% to ≤50%
|
20.9 Percentage of subjects
0
|
18.0 Percentage of subjects
0
|
18.2 Percentage of subjects
0
|
|
Change From Baseline in Daily Corticosteroid Dose at Week 24
No change in dose
|
48.3 Percentage of subjects
0
|
46.7 Percentage of subjects
0
|
52.7 Percentage of subjects
0
|
|
Change From Baseline in Daily Corticosteroid Dose at Week 24
Dose increased or missing data
|
26.2 Percentage of subjects
0
|
25.3 Percentage of subjects
0
|
20.5 Percentage of subjects
0
|
SECONDARY outcome
Timeframe: At Week 48Population: The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.
Participants were grouped into 4 categories: Dose decreased by \>50%, Dose decreased \>0% to ≤50%, No change in dose and Dose increased or missing data.
Outcome measures
| Measure |
Placebo Weekly (FAS)
n=263 Participants
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 1200 mg Every Other Week (FAS)
n=261 Participants
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 600 mg Weekly (FAS)
n=264 Participants
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
|
|---|---|---|---|
|
Change From Baseline in Daily Corticosteroid Dose at Week 48
Dose decreased by >50%
|
6.5 Percentage of participants
0
|
13.8 Percentage of participants
0
|
14.8 Percentage of participants
0
|
|
Change From Baseline in Daily Corticosteroid Dose at Week 48
Dose decreased >0% to ≤50%
|
20.9 Percentage of participants
0
|
13.4 Percentage of participants
0
|
15.9 Percentage of participants
0
|
|
Change From Baseline in Daily Corticosteroid Dose at Week 48
No change in dose
|
35.7 Percentage of participants
0
|
35.6 Percentage of participants
0
|
36.7 Percentage of participants
0
|
|
Change From Baseline in Daily Corticosteroid Dose at Week 48
Dose increased or missing data
|
36.9 Percentage of participants
0
|
37.2 Percentage of participants
0
|
32.6 Percentage of participants
0
|
Adverse Events
Placebo Weekly (SS)
Serious events: 45 serious events
Other events: 151 other events
Deaths: 3 deaths
Epratuzumab 1200 mg Every Other Week (SS)
Serious events: 45 serious events
Other events: 145 other events
Deaths: 1 deaths
Epratuzumab 600 mg Weekly (SS)
Serious events: 50 serious events
Other events: 158 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Weekly (SS)
n=263 participants at risk
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 1200 mg Every Other Week (SS)
n=261 participants at risk
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 600 mg Weekly (SS)
n=264 participants at risk
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
|
|---|---|---|---|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.77%
2/261 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.76%
2/264 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Blood and lymphatic system disorders
Antiphospholipid syndrome
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.77%
2/261 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Cardiac disorders
Lupus myocarditis
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Congenital, familial and genetic disorders
Talipes
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Endocrine disorders
Goitre
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Eye disorders
Necrotising retinitis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Eye disorders
Visual impairment
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Eye disorders
Cataract
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Eye disorders
Retinal degeneration
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.76%
2/263 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.38%
1/263 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
General disorders
Chest pain
|
0.76%
2/263 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
1.5%
4/261 • Number of events 5 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
1.1%
3/264 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
General disorders
Asthenia
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
3/263 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Hepatobiliary disorders
Liver injury
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.1%
3/263 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.77%
2/261 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
1.5%
4/264 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.76%
2/263 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
1.1%
3/264 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.77%
2/261 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Cytomegalovirus chorioretinitis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
3/263 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Eye infection toxoplasmal
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Lobar pneumonia
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Meningitis bacterial
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Pseudomonas infection
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Investigations
Blood pressure increased
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
2.7%
7/263 • Number of events 7 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
2.3%
6/261 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
2.3%
6/264 • Number of events 6 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Convulsion
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Headache
|
1.1%
3/263 • Number of events 3 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Lupus encephalitis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Vasculitis cerebral
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Hemiparesis
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Noninfectious myelitis
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Optic neuritis
|
0.38%
1/263 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on contraceptive
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Renal and urinary disorders
Lupus nephritis
|
0.76%
2/263 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.76%
2/263 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
1.5%
4/264 • Number of events 4 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lupus pleurisy
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lupus pneumonitis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/261 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.77%
2/261 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.77%
2/261 • Number of events 2 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/263 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.38%
1/264 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.38%
1/263 • Number of events 1 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/261 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
0.00%
0/264 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
Other adverse events
| Measure |
Placebo Weekly (SS)
n=263 participants at risk
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 1200 mg Every Other Week (SS)
n=261 participants at risk
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
|
Epratuzumab 600 mg Weekly (SS)
n=264 participants at risk
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
13.7%
36/263 • Number of events 51 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
12.3%
32/261 • Number of events 41 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
9.5%
25/264 • Number of events 38 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.2%
19/263 • Number of events 24 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
5.7%
15/261 • Number of events 15 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
9.5%
25/264 • Number of events 41 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
16/263 • Number of events 18 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
4.6%
12/261 • Number of events 14 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
6.1%
16/264 • Number of events 23 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
General disorders
Fatigue
|
5.3%
14/263 • Number of events 17 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
5.7%
15/261 • Number of events 31 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
5.7%
15/264 • Number of events 18 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
General disorders
Pyrexia
|
6.5%
17/263 • Number of events 19 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
3.1%
8/261 • Number of events 9 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
4.9%
13/264 • Number of events 18 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.1%
37/263 • Number of events 46 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
14.6%
38/261 • Number of events 49 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
14.0%
37/264 • Number of events 47 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
44/263 • Number of events 66 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
14.2%
37/261 • Number of events 45 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
14.4%
38/264 • Number of events 54 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
21/263 • Number of events 23 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
5.7%
15/261 • Number of events 23 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
9.1%
24/264 • Number of events 31 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Sinusitis
|
7.2%
19/263 • Number of events 23 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
4.6%
12/261 • Number of events 17 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
7.6%
20/264 • Number of events 23 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Infections and infestations
Bronchitis
|
8.7%
23/263 • Number of events 24 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
5.0%
13/261 • Number of events 13 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
4.2%
11/264 • Number of events 13 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.2%
19/263 • Number of events 20 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
5.4%
14/261 • Number of events 16 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
5.3%
14/264 • Number of events 14 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Headache
|
16.0%
42/263 • Number of events 68 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
11.1%
29/261 • Number of events 39 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
12.5%
33/264 • Number of events 50 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.9%
13/263 • Number of events 20 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
3.8%
10/261 • Number of events 15 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
5.3%
14/264 • Number of events 16 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Psychiatric disorders
Depression
|
5.7%
15/263 • Number of events 16 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
3.8%
10/261 • Number of events 11 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
3.4%
9/264 • Number of events 10 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
12/263 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
4.6%
12/261 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
6.1%
16/264 • Number of events 19 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
|
Vascular disorders
Hypertension
|
4.6%
12/263 • Number of events 12 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
5.0%
13/261 • Number of events 15 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
6.4%
17/264 • Number of events 17 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60