Trial Outcomes & Findings for Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (NCT NCT01262365)
NCT ID: NCT01262365
Last Updated: 2018-09-28
Results Overview
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. 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
793 participants
Primary outcome timeframe
At Week 48
Results posted on
2018-09-28
Participant Flow
The study started to enroll patients in December 2010 and concluded in May 2015.
Participant Flow refers to the Randomized Set (RS).
Participant milestones
| Measure |
Placebo (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 Per Week (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
|
266
|
262
|
265
|
|
Overall Study
COMPLETED
|
176
|
181
|
171
|
|
Overall Study
NOT COMPLETED
|
90
|
81
|
94
|
Reasons for withdrawal
| Measure |
Placebo (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 Per Week (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
|
35
|
30
|
47
|
|
Overall Study
Protocol Violation
|
3
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
7
|
6
|
|
Overall Study
Withdrawal by Subject
|
17
|
22
|
22
|
|
Overall Study
Death
|
1
|
2
|
1
|
|
Overall Study
Adverse Event
|
26
|
16
|
11
|
|
Overall Study
sponsor decision
|
1
|
1
|
0
|
|
Overall Study
Randomization error
|
1
|
0
|
2
|
|
Overall Study
Non-compliance
|
1
|
0
|
2
|
|
Overall Study
Suspected pregnancy
|
1
|
0
|
0
|
|
Overall Study
Patient pregnant
|
1
|
0
|
1
|
|
Overall Study
Toxicity related to study drug
|
0
|
1
|
0
|
|
Overall Study
Cannot tolerate the protocol
|
0
|
1
|
0
|
|
Overall Study
Patient unavailable
|
0
|
0
|
1
|
Baseline Characteristics
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Placebo (Weekly Infusion)
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
n=259 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 Per Week
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=786 Participants
|
|---|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
252 Participants
n=93 Participants
|
254 Participants
n=4 Participants
|
257 Participants
n=27 Participants
|
763 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 12.6 • n=93 Participants
|
42.5 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
42.3 years
STANDARD_DEVIATION 11.4 • n=27 Participants
|
42.1 years
STANDARD_DEVIATION 12.0 • n=483 Participants
|
|
Sex: Female, Male
Female
|
250 Participants
n=93 Participants
|
243 Participants
n=4 Participants
|
242 Participants
n=27 Participants
|
735 Participants
n=483 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
51 Participants
n=483 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 study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. 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 Infusion) FAS
n=249 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=244 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 Per Week (FAS)
n=248 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
|
34.1 percentage of participants
|
39.8 percentage of participants
|
37.5 percentage of participants
|
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 study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. 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 Infusion) FAS
n=249 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=244 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 Per Week (FAS)
n=248 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
|
33.7 percentage of participants
|
43.0 percentage of participants
|
39.1 percentage of participants
|
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 study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. 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 Infusion) FAS
n=249 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=244 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 Per Week (FAS)
n=248 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
|
31.3 percentage of participants
|
42.2 percentage of participants
|
39.9 percentage of participants
|
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 study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. 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 Infusion) FAS
n=249 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=244 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 Per Week (FAS)
n=248 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
|
33.3 percentage of participants
|
41.8 percentage of participants
|
35.1 percentage of participants
|
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 study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.
Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.
Outcome measures
| Measure |
Placebo (Weekly Infusion) FAS
n=249 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=244 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 Per Week (FAS)
n=248 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%
|
9.2 percentage of participants
|
8.2 percentage of participants
|
6.9 percentage of participants
|
|
Change From Baseline in Daily Corticosteroid Dose at Week 24
Dose decreased >0% to <=50%
|
10.8 percentage of participants
|
16.4 percentage of participants
|
14.9 percentage of participants
|
|
Change From Baseline in Daily Corticosteroid Dose at Week 24
No change in dose
|
52.2 percentage of participants
|
50.0 percentage of participants
|
50.8 percentage of participants
|
|
Change From Baseline in Daily Corticosteroid Dose at Week 24
Dose increased or missing data
|
27.7 percentage of participants
|
25.4 percentage of participants
|
27.4 percentage of participants
|
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 study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.
Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.
Outcome measures
| Measure |
Placebo (Weekly Infusion) FAS
n=249 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=244 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 Per Week (FAS)
n=248 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%
|
14.1 percentage of participants
|
11.9 percentage of participants
|
10.1 percentage of participants
|
|
Change From Baseline in Daily Corticosteroid Dose at Week 48
Dose decreased >0% to <=50%
|
10.4 percentage of participants
|
14.3 percentage of participants
|
12.5 percentage of participants
|
|
Change From Baseline in Daily Corticosteroid Dose at Week 48
No chnage in dose
|
38.6 percentage of participants
|
37.7 percentage of participants
|
37.9 percentage of participants
|
|
Change From Baseline in Daily Corticosteroid Dose at Week 48
Dose increased or missing data
|
36.9 percentage of participants
|
36.1 percentage of participants
|
39.5 percentage of participants
|
Adverse Events
Placebo (Weekly Infusion)
Serious events: 48 serious events
Other events: 144 other events
Deaths: 1 deaths
Epratuzumab 1200 mg Every Other Week
Serious events: 44 serious events
Other events: 153 other events
Deaths: 2 deaths
Epratuzumab 600 mg Per Week
Serious events: 45 serious events
Other events: 141 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo (Weekly Infusion)
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
n=259 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 Per Week
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
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.77%
2/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Cardiac disorders
Pericarditis lupus
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Cardiac disorders
Pericarditis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Congenital, familial and genetic disorders
Cerebrovascular arteriovenous malformation
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Endocrine disorders
Hyperparathyroidism
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Eye disorders
Retinal detachment
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Bezoar
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
General disorders
Inflammation
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
General disorders
Non-cardiac 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
General disorders
Serositis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.77%
2/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Lupus hepatitis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Immune system disorders
Serum sickness
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
1.2%
3/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
1.2%
3/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.5%
4/263 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Abscess limb
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Abscess neck
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Atypical pneumonia
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial pyelonephritis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Bronchopneumonia
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Erysipelas
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster meningitis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Localised 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Lymphangitis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Myringitis bullous
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Pelvic inflammatory 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis acute
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis chronic
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Pyomyositis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Diarrhoea infectious
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Pneumococcal sepsis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Viral 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fibula 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Investigations
Hepatic enzyme 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Investigations
Weight 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Obesity
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
1.9%
5/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.38%
1/264 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Nervous system disorders
Carotid artery thrombosis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Nervous system disorders
Lupus encephalitis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Nervous system disorders
Mononeuropathy multiplex
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium tremens
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Bipolar I disorder
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.77%
2/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrotic 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.77%
2/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Breast ulceration
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Endometriosis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.77%
2/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Vascular disorders
Thrombophlebitis superficial
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.39%
1/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Vascular disorders
Arteriosclerosis
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Vascular disorders
Jugular 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Vascular disorders
Lupus 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
0.00%
0/259 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo (Weekly Infusion)
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
n=259 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 Per Week
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
|
|---|---|---|---|
|
General disorders
Fatigue
|
3.8%
10/263 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
6.6%
17/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
4.5%
12/264 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
8.7%
23/263 • Number of events 28 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
11.6%
30/259 • Number of events 44 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
14.4%
38/264 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
8.1%
21/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
7.2%
19/264 • Number of events 28 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.4%
30/263 • Number of events 36 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
12.4%
32/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
12.1%
32/264 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
11.4%
30/263 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
9.7%
25/259 • Number of events 29 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
10.2%
27/264 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
21/263 • Number of events 26 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
7.7%
20/259 • Number of events 21 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
8.3%
22/264 • Number of events 29 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
4.9%
13/263 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
9.3%
24/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
5.7%
15/264 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
7.6%
20/263 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
4.6%
12/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
14/263 • Number of events 21 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
7.7%
20/259 • Number of events 28 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
5.3%
14/264 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
10/263 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
7.3%
19/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
5.7%
15/264 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
11/263 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
5.4%
14/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
3.4%
9/264 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
11.0%
29/263 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
13.1%
34/259 • Number of events 42 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
14.4%
38/264 • Number of events 58 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.2%
11/263 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
3.5%
9/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
6.1%
16/264 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
1.1%
3/263 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
6.2%
16/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
2.7%
7/264 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
12/263 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
5.0%
13/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
4.5%
12/264 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
5/263 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
5.4%
14/259 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
3.0%
8/264 • Number of events 8 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
4.2%
11/263 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
7.7%
20/259 • Number of events 21 • Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
4.9%
13/264 • 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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60