Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis (NCT NCT00282347)
NCT ID: NCT00282347
Last Updated: 2015-01-15
Results Overview
A participant had a CRR if they met the following 3 criteria: (1) Normalization of serum creatinine (SC) as evidenced by a SC level ≤ the upper limit of the normal range of central laboratory values or a SC level ≤ 15% greater than Baseline, if Baseline SC was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by \< 5 red blood cells/high-power field (RBCs/HPF) and absence of red cell casts; (3) Urinary protein (UP) to creatinine ratio (CR) \< 0.5. A participant had a PRR if they met the following 3 criteria: (1) A SC level ≤ 15% above Baseline; (2) RBCs/HPF ≤ 50% above Baseline and no RBC casts; (3) 50% improvement in the UP to CR, with 1 of the following conditions met: If the Baseline UP to CR was ≤ 3.0, then a UP to CR of \< 1.0 or if the Baseline UP to CR was \> 3.0, then a UP to CR of ≤ 3.0. A participant had a NRR if they did not achieve either a CRR or PRR.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
144 participants
Primary outcome timeframe
Week 52
Results posted on
2015-01-15
Participant Flow
Participant milestones
| Measure |
Rituximab
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
|---|---|---|
|
Treatment Period
STARTED
|
72
|
72
|
|
Treatment Period
COMPLETED
|
67
|
63
|
|
Treatment Period
NOT COMPLETED
|
5
|
9
|
|
Safety Follow-up Period
STARTED
|
67
|
63
|
|
Safety Follow-up Period
COMPLETED
|
64
|
57
|
|
Safety Follow-up Period
NOT COMPLETED
|
3
|
6
|
|
B Cell Follow-up Period
STARTED
|
20
|
4
|
|
B Cell Follow-up Period
COMPLETED
|
15
|
4
|
|
B Cell Follow-up Period
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Rituximab
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
|---|---|---|
|
Treatment Period
Death
|
2
|
0
|
|
Treatment Period
Lost to Follow-up
|
2
|
5
|
|
Treatment Period
Withdrawal by Subject
|
1
|
3
|
|
Treatment Period
Physician Decision
|
0
|
1
|
|
Safety Follow-up Period
Lost to Follow-up
|
0
|
2
|
|
Safety Follow-up Period
Withdrawal by Subject
|
2
|
1
|
|
Safety Follow-up Period
Physician Decision
|
1
|
1
|
|
Safety Follow-up Period
Protocol Deviation
|
0
|
2
|
|
B Cell Follow-up Period
Withdrawal by Subject
|
2
|
0
|
|
B Cell Follow-up Period
Physician Decision
|
1
|
0
|
|
B Cell Follow-up Period
Reason Not Specified
|
2
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis
Baseline characteristics by cohort
| Measure |
Rituximab
n=72 Participants
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo
n=72 Participants
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 18 years
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Age, Customized
18 to < 35 years
|
48 participants
n=99 Participants
|
48 participants
n=107 Participants
|
96 participants
n=206 Participants
|
|
Age, Customized
35 to < 50 years
|
18 participants
n=99 Participants
|
19 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Age, Customized
≥ 50 years
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Age, Continuous
|
31.8 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
29.4 years
STANDARD_DEVIATION 9.3 • n=107 Participants
|
30.6 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
A participant had a CRR if they met the following 3 criteria: (1) Normalization of serum creatinine (SC) as evidenced by a SC level ≤ the upper limit of the normal range of central laboratory values or a SC level ≤ 15% greater than Baseline, if Baseline SC was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by \< 5 red blood cells/high-power field (RBCs/HPF) and absence of red cell casts; (3) Urinary protein (UP) to creatinine ratio (CR) \< 0.5. A participant had a PRR if they met the following 3 criteria: (1) A SC level ≤ 15% above Baseline; (2) RBCs/HPF ≤ 50% above Baseline and no RBC casts; (3) 50% improvement in the UP to CR, with 1 of the following conditions met: If the Baseline UP to CR was ≤ 3.0, then a UP to CR of \< 1.0 or if the Baseline UP to CR was \> 3.0, then a UP to CR of ≤ 3.0. A participant had a NRR if they did not achieve either a CRR or PRR.
Outcome measures
| Measure |
Rituximab
n=72 Participants
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo
n=72 Participants
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52
CRR
|
26.4 Percentage of participants
|
30.6 Percentage of participants
|
|
Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52
PRR
|
30.6 Percentage of participants
|
15.3 Percentage of participants
|
|
Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52
NRR
|
43.1 Percentage of participants
|
54.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24 to Week 52Population: Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by \< 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio \< 0.5.
Outcome measures
| Measure |
Rituximab
n=72 Participants
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo
n=72 Participants
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52
|
1.4 Percentage of participants
|
6.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by \< 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio \< 0.5.
Outcome measures
| Measure |
Rituximab
n=72 Participants
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo
n=72 Participants
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Complete Renal Response at Week 52
|
26.4 Percentage of participants
|
30.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo). Only those participants with a Baseline urine protein to creatinine ratio of \> 3.0 were included in the analysis.
Outcome measures
| Measure |
Rituximab
n=38 Participants
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo
n=41 Participants
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
|---|---|---|
|
Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52
|
47.4 Percentage of participants
|
53.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
The BILAG Index assesses 86 clinical signs and symptoms and laboratory measures of systemic lupus erythematosus in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic. Most of the 86 items are rated on the following scale: 0=Not present, 1=Improving, 2=Same, 3=Worse, 4=New. Some items are rated as either Yes or No. A single alphabetic score of A (very active) through E (not or never active) for each of the 8 domains is determined from the rating of the individual items in each domain. The total BILAG score is the sum of the scores of the 8 domains where A=9, B=3, C=1, D=0, and E=0. The total score ranges from 0 to 72 with a higher score indicating greater lupus activity. To calculate a BILAG score over the 52 week treatment period of the study, the area under the response-time curve of BILAG scores assessed every 4 weeks was divided by the number of days in the time curve minus the Baseline BILAG score.
Outcome measures
| Measure |
Rituximab
n=72 Participants
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo
n=72 Participants
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
|---|---|---|
|
British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks
|
-8.49 Units on a scale
Standard Deviation 5.79
|
-8.58 Units on a scale
Standard Deviation 5.14
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
Outcome measures
| Measure |
Rituximab
n=72 Participants
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo
n=72 Participants
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
|---|---|---|
|
Time to Achieve a Complete Renal Response
|
11.99 Weeks
Interval 8.31 to
The upper limit of the confidence interval could not be estimated due to too few events.
|
12.12 Weeks
Interval 9.26 to 13.47
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
The systemic lupus erythematosus Expanded Health Survey is based on the Short Form 36 Health survey with additional questions specific to lupus. The physical function component score of the survey can range from 0-100. A higher score indicates better health. A positive change score indicates improvement.
Outcome measures
| Measure |
Rituximab
n=72 Participants
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo
n=72 Participants
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
|---|---|---|
|
Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52
|
4.8 Units on a scale
Standard Deviation 10.4
|
5.7 Units on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
Outcome measures
| Measure |
Rituximab
n=72 Participants
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo
n=72 Participants
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
|---|---|---|
|
Change From Baseline in Anti-double-stranded DNA at Week 52
|
0.45 IU/mL
Standard Deviation 0.35
|
1.06 IU/mL
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
Outcome measures
| Measure |
Rituximab
n=72 Participants
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo
n=72 Participants
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
|---|---|---|
|
Change From Baseline in C3 and C4 Complement Levels at Week 52
C3 Complement
|
37.5 mg/dL
Standard Deviation 28.7
|
25.9 mg/dL
Standard Deviation 32.5
|
|
Change From Baseline in C3 and C4 Complement Levels at Week 52
C4 Complement
|
9.9 mg/dL
Standard Deviation 7.5
|
6.6 mg/dL
Standard Deviation 8.9
|
Adverse Events
Rituximab - Treatment and Safety Follow-up Periods
Serious events: 24 serious events
Other events: 69 other events
Deaths: 0 deaths
Placebo - Treatment and Safety Follow-up Periods
Serious events: 29 serious events
Other events: 66 other events
Deaths: 0 deaths
Rituximab - B Cell Follow-up Period
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo - B Cell Follow-up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab - Treatment and Safety Follow-up Periods
n=73 participants at risk
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo - Treatment and Safety Follow-up Periods
n=71 participants at risk
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Rituximab - B Cell Follow-up Period
n=20 participants at risk
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo - B Cell Follow-up Period
n=4 participants at risk
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.1%
3/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
4.2%
3/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.7%
2/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.7%
2/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Cardiac disorders
Myocardial Infarction
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Endocrine disorders
Thyroiditis
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
General disorders
Chest Pain
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
2.8%
2/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
General disorders
Drug Intolerance
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
General disorders
Generalized Oedema
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
General disorders
Oedema
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Immune system disorders
Antiphospholipid Syndrome
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Pneumonia
|
2.7%
2/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
4.2%
3/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Cellulitis
|
2.7%
2/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Herpes Zoster
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
2.8%
2/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Bronchopneumonia
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
2.8%
2/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Urinary Tract Infection
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Bacteraemia
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Bacterial Infection
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Catheter Related Infection
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Cytomegalovirus Colitis
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Fungal Sepsis
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Genital Herpes
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Histoplasmosis
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Impetigo
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Pneumonia Cryptococcal
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Pneumonia Cytomegaloviral
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Sepsis
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Soft Tissue Infection
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Investigations
International Normalized Ratio Decreased
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
2.8%
2/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
2.8%
2/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Nervous system disorders
Vasculitis Cerebral
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Nervous system disorders
Hypersensitive Encephalopathy
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Nervous system disorders
Ruptured Cerebral Aneurysm
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Nervous system disorders
Syncope
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Psychiatric disorders
Depression
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Psychiatric disorders
Psychotic Disorder
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
4.2%
3/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.7%
2/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Skin and subcutaneous tissue disorders
Rash Vesicular
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Vascular disorders
Hypertension
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
2.8%
2/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Vascular disorders
Hypotension
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Vascular disorders
Malignant Hypertension
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Vascular disorders
Thrombosis
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Vascular disorders
Vena Cava Thrombosis
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.0%
1/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.0%
1/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Blood and lymphatic system disorders
Nephrogenic anemia
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.0%
1/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Surgical and medical procedures
Renal transplant
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.0%
1/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
Other adverse events
| Measure |
Rituximab - Treatment and Safety Follow-up Periods
n=73 participants at risk
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo - Treatment and Safety Follow-up Periods
n=71 participants at risk
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Rituximab - B Cell Follow-up Period
n=20 participants at risk
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
Placebo - B Cell Follow-up Period
n=4 participants at risk
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
9.6%
7/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
2.8%
2/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Blood and lymphatic system disorders
Anaemia
|
13.7%
10/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
12.7%
9/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Cardiac disorders
Tachycardia
|
8.2%
6/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
7.0%
5/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Cardiac disorders
Palpitations
|
2.7%
2/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Endocrine disorders
Cushingoid
|
5.5%
4/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
2.8%
2/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Eye disorders
Conjunctivitis
|
4.1%
3/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Eye disorders
Vision Blurred
|
4.1%
3/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Diarrhoea
|
38.4%
28/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
39.4%
28/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Nausea
|
27.4%
20/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
29.6%
21/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Vomiting
|
26.0%
19/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
19.7%
14/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.8%
5/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
12.7%
9/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
2.7%
2/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
9.9%
7/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.5%
4/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.5%
4/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.1%
3/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
5.5%
4/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
2.8%
2/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Dental Caries
|
5.5%
4/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
2.8%
2/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.5%
4/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
2.8%
2/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
General disorders
Oedema Peripheral
|
8.2%
6/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
15.5%
11/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
General disorders
Oedema
|
11.0%
8/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
9.9%
7/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
General disorders
Chest Pain
|
5.5%
4/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
14.1%
10/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
General disorders
Pyrexia
|
12.3%
9/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
General disorders
Chills
|
2.7%
2/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
General disorders
Pain
|
2.7%
2/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Immune system disorders
Seasonal Allergy
|
6.8%
5/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
General disorders
Fatigue
|
16.4%
12/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
12.7%
9/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
28.8%
21/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
32.4%
23/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.0%
1/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Urinary Tract Infection
|
23.3%
17/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
28.2%
20/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
15.0%
3/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Herpes Zoster
|
15.1%
11/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
11.3%
8/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Gastroenteritis
|
11.0%
8/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
9.9%
7/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Nasopharyngitis
|
11.0%
8/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
7.0%
5/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.0%
1/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Sinusitis
|
12.3%
9/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Bronchitis
|
8.2%
6/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Oral Candidiasis
|
8.2%
6/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Candidiasis
|
5.5%
4/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
4.2%
3/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Cellulitis
|
4.1%
3/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Influenza
|
4.1%
3/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Gastroenteritis Viral
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.8%
5/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Investigations
Blood Potassium Decreased
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.7%
10/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
14.1%
10/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
11.0%
8/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
4.2%
3/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
23.3%
17/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
25.4%
18/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.9%
16/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
22.5%
16/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
12.3%
9/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
12.7%
9/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.2%
6/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
15.5%
11/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
8.2%
6/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.1%
3/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
8.5%
6/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
2.7%
2/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Nervous system disorders
Headache
|
35.6%
26/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
26.8%
19/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Nervous system disorders
Dizziness
|
12.3%
9/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
7.0%
5/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Nervous system disorders
Tremor
|
4.1%
3/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
7.0%
5/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Nervous system disorders
Dysgeusia
|
2.7%
2/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
7.0%
5/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Nervous system disorders
Hypoaesthesia
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
7.0%
5/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Psychiatric disorders
Insomnia
|
13.7%
10/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
19.7%
14/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Psychiatric disorders
Anxiety
|
6.8%
5/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
11.3%
8/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Psychiatric disorders
Depression
|
6.8%
5/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
8.5%
6/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.9%
16/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
18.3%
13/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.8%
5/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
9.9%
7/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
2/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.7%
2/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
1.4%
1/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.6%
4/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
5.5%
4/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.7%
10/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
8.5%
6/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.6%
7/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
11.3%
8/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.1%
3/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
11.3%
8/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
5.5%
4/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
1.4%
1/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Vascular disorders
Hypertension
|
9.6%
7/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
9.9%
7/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Vascular disorders
Hypotension
|
11.0%
8/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
4.2%
3/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.0%
1/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.0%
1/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.0%
1/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.0%
1/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Ear and labyrinth disorders
Ear infection
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.0%
1/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Endocrine disorders
Amenorrhoea
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.0%
1/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/73 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/71 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
5.0%
1/20 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
0.00%
0/4 • Baseline to the end of the study (up to 7 years)
Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.
|
Additional Information
Medical Communications
Genentech, Inc.
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER